Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- EAGCephalometer2Product Code
- EAHCone, Radiographic, Lead-Lined1Product Code
- EAPUnit, X-Ray, Intraoral2Product Code
- EHBCollimator, X-Ray1Product Code
- EHDUnit, X-Ray, Extraoral With Timer2Product Code
- MUHSystem, X-Ray, Extraoral Source, Digital2Product Code
- EAMScreen, Intensifying, Radiographic1Product Code
- EGTController, Temperature, Radiographic2Product Code
- EGWDryer, Film, Radiographic2Product Code
- EGYProcessor, Radiographic-Film, Automatic, Dental2Product Code
- HBKChair, Pneumoencephalographic2Product Code
- ITXTransducer, Ultrasonic, Diagnostic2Product Code
- ITYAssembly, Tube Housing, X-Ray, Diagnostic1Product Code
- IWNCassette, Measurement, Ardran-Crooks1Product Code
- IWYHolder, Head, Radiographic1Product Code
- IWZFilm, Radiographic1Product Code
- IXACassette, Radiographic Film2Product Code
- IXCIlluminator, Radiographic-Film1Product Code
- IXDSource, Calibration, Sealed, Nuclear1Product Code
- IXFTest-Pattern, Radiographic1Product Code
- IXGPhantom, Anthropomorphic, Radiographic1Product Code
- IXHCamera, Focal Spot, Radiographic1Product Code
- IXJGrid, Radiographic1Product Code
- IXKSystem, Imaging, X-Ray, Electrostatic2Product Code
- IXLDevice, Spot-Film2Product Code
- IXOSynchronizer, Ecg / Respirator, Radiographic1Product Code
- IXQTable, Radiographic, Stationary Top2Product Code
- IXRTable, Radiographic, Tilting2Product Code
- IXWProcessor, Radiographic-Film, Automatic2Product Code
- IXXProcessor, Cine Film2Product Code
- IXYHolder, Radiographic Cassette, Wall-Mounted1Product Code
- IYBTube Mount, X-Ray, Diagnostic1Product Code
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2Product Code
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic2Product Code
- IYPPhantom, Anthropomorphic, Nuclear1Product Code
- IYQPhantom, Flood Source, Nuclear1Product Code
- IYTSystem, Rebreathing, Radionuclide2Product Code
- IYWScanner, Rectilinear, Nuclear1Product Code
- IYXCamera, Scintillation (Gamma)1Product Code
- IYYSynchronizer, Electrocardiograph, Nuclear1Product Code
- IYZBed, Scanning, Nuclear1Product Code
- IZCCamera, Positron1Product Code
- IZDProbe, Uptake, Nuclear1Product Code
- IZFSystem, X-Ray, Tomographic2Product Code
- IZGSystem, X-Ray, Photofluorographic2Product Code
- IZHSystem, X-Ray, Mammographic2Product Code
- IZISystem, X-Ray, Angiographic2Product Code
- IZJCamera, X-Ray, Fluorographic, Cine Or Spot2Product Code
- IZLSystem, X-Ray, Mobile2Product Code
- IZOGenerator, High-Voltage, X-Ray, Diagnostic1Product Code
- IZPProgrammer, Changer, Film/Cassette, Radiographic2Product Code
- IZSAperture, Radiographic2Product Code
- IZTCone, Radiographic2Product Code
- IZWCollimator, Automatic, Radiographic2Product Code
- IZXCollimator, Manual, Radiographic2Product Code
- IZZTable, Radiographic, Non-Tilting, Powered2Product Code
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified2Product Code
- JABSystem, X-Ray, Fluoroscopic, Non-Image-Intensified2Product Code
- JACSystem, X-Ray, Film Marking, Radiographic1Product Code
- JAFMonitor, Ultrasonic, Nonfetal2Product Code
- JAGIlluminator, Radiographic-Film, Explosion-Proof1Product Code
- JAKSystem, X-Ray, Tomography, Computed2Product Code
- JAMScanner, Whole Body, Nuclear1Product Code
- JANCounter, Whole Body, Nuclear1Product Code
- JAOScanner, Fluorescent2Product Code
- JARPhantom, Test-Pattern, Radionuclide1Product Code
- JWMSystem, Tomographic, Nuclear2Product Code
- KGIDensitometer, Bone2Product Code
- KPRSystem, X-Ray, Stationary2Product Code
- KPSSystem, Tomography, Computed, Emission2Product Code
- KPTCalibrator, Dose, Radionuclide2Product Code
- KPWDevice, Beam Limiting, X-Ray, Diagnostic2Product Code
- KPXChanger, Radiographic Film/Cassette2Product Code
- KXHCradle, Patient, Radiologic1Product Code
- KXJTable, Radiologic2Product Code
- LEKTransilluminator (Diaphanoscope)3Product Code
- LHOInstrument, Quality-Assurance, Radiologic1Product Code
- LLZSystem, Image Processing, Radiological2Product Code
- K241495Jazz Classic2Cleared 510(K)
- K242329CT Collaboration Live2Cleared 510(K)
- K2420621CMR Pro2Cleared 510(K)
- K241981Change Healthcare Stratus Imaging PACS2Cleared 510(K)
- K242709JLK-PWI2Cleared 510(K)
- K241223eRAD PACS2Cleared 510(K)
- K242512ROCC Console2Cleared 510(K)
- K243012MIM – Symphony HDR Fusion2Cleared 510(K)
- K243209nordicMEDiVA2Cleared 510(K)
- K242556JLK-CTP2Cleared 510(K)
- K240385VINT2Cleared 510(K)
- K241569syngo Application Software2Cleared 510(K)
- K240243EConsole22Cleared 510(K)
- K241524Elucid PlaqueIQ2Cleared 510(K)
- K233998TRAQinform IQ2Cleared 510(K)
- K241302SonoSync2Cleared 510(K)
- K240290AiMIFY (1.x)2Cleared 510(K)
- K241094Bullsai2Cleared 510(K)
- K240724SynthVISION 1.0.02Cleared 510(K)
- K233761Orthopaedic Surgery Planning Software (AIJOINT)2Cleared 510(K)
- K241114EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)2Cleared 510(K)
- K241879vRad Viewer2Cleared 510(K)
- K241121MICSI-RMT2Cleared 510(K)
- K240705Vitrea Software Package, VSTP-002A V2.02Cleared 510(K)
- K241300ViewPoint 62Cleared 510(K)
- K233908cNeuro cDAT2Cleared 510(K)
- K241608nordicMEDiVA2Cleared 510(K)
- K233331MediOMx2Cleared 510(K)
- K240281Bone Suppression Software2Cleared 510(K)
- K223427Mimics Enlight CMF2Cleared 510(K)
- K240294Syngo Carbon Enterprise Access (VA40A)2Cleared 510(K)
- K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout2Cleared 510(K)
- K233620MIM - Centiloid Scaling2Cleared 510(K)
- K232862MIM – Monte Carlo Dosimetry2Cleared 510(K)
- K232976VUZE System2Cleared 510(K)
- K232514MIM – Dose Analysis2Cleared 510(K)
- K233699SubtleREFORMAT (1.x)2Cleared 510(K)
- K240839OpenRad Cloud2Cleared 510(K)
- K240822Image Management V152Cleared 510(K)
- K233582Rapid2Cleared 510(K)
- K232641Neorad Pacs (Neorad Pacs)2Cleared 510(K)
- K232891CARPL (CARPL)2Cleared 510(K)
- K240620Cube Navigator2Cleared 510(K)
- K233660nCommand Lite System2Cleared 510(K)
- K233599X-Clever (ASHK100G)2Cleared 510(K)
- K233930MRCP+ version 2 (MRCP+ v2)2Cleared 510(K)
- K233572Autofuse2Cleared 510(K)
- K233217Mimics Cardiac Planner2Cleared 510(K)
- K231662Aid-U2Cleared 510(K)
- K232339Augmented Reality Application2Cleared 510(K)
- K232007CAAS MR Solutions2Cleared 510(K)
- K231396CEPHX- Cephalometric Analysis Software2Cleared 510(K)
- K233714BreView2Cleared 510(K)
- K231607Axial3D Cloud Segmentation Service2Cleared 510(K)
- K233226FlexView Diagnostic (v1.1.20)2Cleared 510(K)
- K232589Horos MD™2Cleared 510(K)
- K232744syngo Virtual Cockpit (VB10A)2Cleared 510(K)
- K233176uOmnispace.MI2Cleared 510(K)
- K230955syngo Application Software2Cleared 510(K)
- K231570StrokeViewer Perfusion2Cleared 510(K)
- K233634TeleScan2Cleared 510(K)
- K231898DTX Studio Clinic (4.0)2Cleared 510(K)
- K223757Bonelogic2Cleared 510(K)
- K232661Myocardial Strain Software Application2Cleared 510(K)
- K231498TraumaCad Neo2Cleared 510(K)
- K230856BrainSpec Core™ Software2Cleared 510(K)
- K230854SwiftMR2Cleared 510(K)
- K232086spineEOS2Cleared 510(K)
- K223909R2GATE Lite TM2Cleared 510(K)
- K231225EConsole12Cleared 510(K)
- K230249Ikshana2Cleared 510(K)
- K231642Veuron-Brain-pAb32Cleared 510(K)
- K230252OFIX MIS App2Cleared 510(K)
- K223659Jazz2Cleared 510(K)
- K231385Rology Teleradiology Platform (v.1.22.1103)2Cleared 510(K)
- K232189OrionXR2Cleared 510(K)
- K231353AccuCTP Pro2Cleared 510(K)
- K220034NEUROShield2Cleared 510(K)
- K231047UniSyn Molecular Imaging (6-3-1)2Cleared 510(K)
- K231656Brainomix 360 e-MRI2Cleared 510(K)
- K223180AIRAscore2Cleared 510(K)
- K231503CUPTIMIZE™ Advanced2Cleared 510(K)
- K223660SaintView2Cleared 510(K)
- K232100Efai Pacs Picture Archiving and Communication System Pro2Cleared 510(K)
- K230540Patient Specific Planning Solution™ 3D Bone Models2Cleared 510(K)
- K223322Argus Cognitive ReVISION Software2Cleared 510(K)
- K222683Fibroid Mapping Reviewer Application (FMRA)2Cleared 510(K)
- K231041JiveX (Model Number / Release: 5.4)2Cleared 510(K)
- K230016Cercare Medical Neurosuite2Cleared 510(K)
- K223290CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)2Cleared 510(K)
- K231351Chondral Quant2Cleared 510(K)
- K223125XR90 (XR90-SYS)2Cleared 510(K)
- K213253Pixyl.Neuro2Cleared 510(K)
- K223048Medisystem Pacs2Cleared 510(K)
- K223091CT Perfusion V1.02Cleared 510(K)
- K231360Ambra PACS2Cleared 510(K)
- K223532Olea S.I.A. Neurovascular V1.02Cleared 510(K)
- K223555Brainomix 360 e-CTP2Cleared 510(K)
- K223841KBA3D2Cleared 510(K)
- K222359Quicktome Software Suite2Cleared 510(K)
- K230044Pre-Sure2Cleared 510(K)
- K222035Avatar Medical Software V12Cleared 510(K)
- K231162ROSA Hip System2Cleared 510(K)
- K230803ADAS 3D2Cleared 510(K)
- K212758Autoplaque2Cleared 510(K)
- K222854iTFlow2Cleared 510(K)
- K223623SubtleMR (2.3.x)2Cleared 510(K)
- K222987Akunah REFLECT2Cleared 510(K)
- K220437Neurophet AQUA2Cleared 510(K)
- K2301193D Anatomic Model2Cleared 510(K)
- K221870CarnaLife Holo2Cleared 510(K)
- K230552MR DWI/FLAIR Measurement V1.02Cleared 510(K)
- K230906Konicaminolta DI-X12Cleared 510(K)
- K230468EzDent Web2Cleared 510(K)
- K230772Quantib Prostate2Cleared 510(K)
- K230393UniCam Evo Software2Cleared 510(K)
- K230264Ezra Flash2Cleared 510(K)
- K222781Augmento2Cleared 510(K)
- K230575Limbus Contour2Cleared 510(K)
- K213660RadAlly2Cleared 510(K)
- K211059CereFlow V1.22Cleared 510(K)
- K221984InterView XP; InterView FUSION2Cleared 510(K)
- K230561Syngo Carbon Space VA30A2Cleared 510(K)
- K223490FlightPlan for Embolization2Cleared 510(K)
- K230294CoverScan (CoverScan v1.1)2Cleared 510(K)
- K222975Advantis Platform2Cleared 510(K)
- K221680Xeleris V Processing and Review System2Cleared 510(K)
- K222757Clarus Viewer2Cleared 510(K)
- K213891RealNow2Cleared 510(K)
- K223820EzDent-i / E2 / Prora View/ Smart M Viewer2Cleared 510(K)
- K230196syngo.via View&GO VA40A2Cleared 510(K)
- K223425MD.ai Viewer2Cleared 510(K)
- K230012Atomica Planner2Cleared 510(K)
- K221725Advanced MyHip Planner2Cleared 510(K)
- K221627PerfusionGo Plus2Cleared 510(K)
- K222593TruPlan Computed Tomography (CT) Imaging Software2Cleared 510(K)
- K223800MIM – Additional Tracers2Cleared 510(K)
- K220649Elucis2Cleared 510(K)
- K223502MR Diffusion Perfusion Mismatch V1.02Cleared 510(K)
- K223363MAMMOVISTA B.smart (VB70)2Cleared 510(K)
- K222458AIBOLIT 3D+2Cleared 510(K)
- K223336Vitrea Software Package, VSTP-002A2Cleared 510(K)
- K222577TECHFIT Diagnostic Models2Cleared 510(K)
- K213263OnyxCeph2Cleared 510(K)
- K222767PeekMed web (v1)2Cleared 510(K)
- K222195aprevo® Digital Workflow2Cleared 510(K)
- K221796Cyware 4H and Cysart 4H2Cleared 510(K)
- K223071Xenoview VDP2Cleared 510(K)
- K222320MedDream2Cleared 510(K)
- K220630TorchTM Software2Cleared 510(K)
- K213215VSI HoloMedicine2Cleared 510(K)
- K223152Vision 2, EVARVision, TrackVision 2, HeartVision 22Cleared 510(K)
- K222054Denti.AI Auto-Chart2Cleared 510(K)
- K221499Minimally Invasive Prostate Surgery Navigation System2Cleared 510(K)
- K220663AccuCTP2Cleared 510(K)
- K222476OmegaAI Image Viewer2Cleared 510(K)
- K221677Synapse 3D Base Tools v6.62Cleared 510(K)
- K221478Dolphin Blue Imaging2Cleared 510(K)
- K2224703Dicom MD2Cleared 510(K)
- K213128IntraOp VSP Software Device2Cleared 510(K)
- K222662Vitrea CT Cardiac Analysis2Cleared 510(K)
- K221501syngo.via View&GO2Cleared 510(K)
- K220758e-Ortho Shoulder Software v1.12Cleared 510(K)
- K222069Ez3D-i/E32Cleared 510(K)
- K213520AXIR-CX2Cleared 510(K)
- K220903WebCeph2Cleared 510(K)
- K220433syngo Application Software (VE21)2Cleared 510(K)
- K222145EzDent-i / E2 / Prora View/ Smart M Viewer2Cleared 510(K)
- K220349TeraRecon Neuro2Cleared 510(K)
- K222072Dolphin Imaging 12.02Cleared 510(K)
- K221405Neurophet SCALE PET2Cleared 510(K)
- K220733OptiVu ROSA MxR2Cleared 510(K)
- K220624AI4CMR v1.02Cleared 510(K)
- K213922FX SPS2Cleared 510(K)
- K220039AutoSeg2Cleared 510(K)
- K221426Functional MR V1.02Cleared 510(K)
- K221511Axial3D Cloud Segmentation Service2Cleared 510(K)
- K213665Syngo Carbon Space VA20A2Cleared 510(K)
- K221463ElucidVivo A.32Cleared 510(K)
- K213684SurgiCase Viewer2Cleared 510(K)
- K221065MediLab2Cleared 510(K)
- K2202053D Anatomic Models2Cleared 510(K)
- K221270EchoNavigator R4.02Cleared 510(K)
- K220416SwiftMR2Cleared 510(K)
- K221000ON3D2Cleared 510(K)
- K220832syngo Dynamics (Version VA40E)2Cleared 510(K)
- K212565CoverScan v12Cleared 510(K)
- K212376Caas Qardia2Cleared 510(K)
- K221106Quantib Prostate2Cleared 510(K)
- K220727inHEART MODELS2Cleared 510(K)
- K213975KEOPS Balance Analyzer 3D2Cleared 510(K)
- K211966Segment 3DPrint2Cleared 510(K)
- K213302exoplan2Cleared 510(K)
- K220684Oryx Cloud Imaging2Cleared 510(K)
- K220590aPROMISE X2Cleared 510(K)
- K211713AngioCloud Service2Cleared 510(K)
- K212981MirrorMe3D Modeling System2Cleared 510(K)
- K220779XD2Cleared 510(K)
- K220767TeleScan2Cleared 510(K)
- K203783ClariPulmo2Cleared 510(K)
- K213562DTX Studio Clinic 3.02Cleared 510(K)
- K212040RI.HIP MODELER2Cleared 510(K)
- K212720nordicDSC2Cleared 510(K)
- K220003EzOrtho v1.32Cleared 510(K)
- K213165Rapid2Cleared 510(K)
- K213801Veuron-Brain-pAb22Cleared 510(K)
- K213737Quantib ND2Cleared 510(K)
- K212005UNiD Spine Analyzer2Cleared 510(K)
- K211443AIBOLIT 3D+2Cleared 510(K)
- K210830VUZE System2Cleared 510(K)
- K211156CONVIVO In Vivo Pathology Suite2Cleared 510(K)
- K213140Claritas iPET2Cleared 510(K)
- K210931Libby IAAA v1.02Cleared 510(K)
- K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio2Cleared 510(K)
- K211114Will3D2Cleared 510(K)
- K211039BIT-Motion2Cleared 510(K)
- K212137X-Clever2Cleared 510(K)
- K203743EXA2Cleared 510(K)
- K210916PVmed Contouring Software2Cleared 510(K)
- K210241ImplaStation2Cleared 510(K)
- K211432Myomics Q2Cleared 510(K)
- K212984MiPACS HTML5 Web Viewer2Cleared 510(K)
- K212621MAMMOVISTA B.smart2Cleared 510(K)
- K211876Intellijoint VIEW2Cleared 510(K)
- K212887RTapp2Cleared 510(K)
- K210344inVisionOS2Cleared 510(K)
- K212550Hura CTP v1.02Cleared 510(K)
- K211356GIQuant2Cleared 510(K)
- K212896Visible Patient Suite2Cleared 510(K)
- K213326VisionX 3.02Cleared 510(K)
- K211987ATEC Alignment App2Cleared 510(K)
- K210807FlightPlan for Liver2Cleared 510(K)
- K212470iRAD2Cleared 510(K)
- K212528Change Healthcare Cardiology2Cleared 510(K)
- K210999SwiftMR2Cleared 510(K)
- K202808Brainance MD2Cleared 510(K)
- K211429NAVIPLAN - CT Planning Software for Total Hip Replacement2Cleared 510(K)
- K211795EzDent-i/ E2/ Prora View/ Smart M Viewer2Cleared 510(K)
- K210726ImmersiveTouch2Cleared 510(K)
- K211700EzDent Web2Cleared 510(K)
- K212777Collaboration Live2Cleared 510(K)
- K212321JiveX (Model Number / Release: 5.3)2Cleared 510(K)
- K212685KONICAMINOLTA DI-X12Cleared 510(K)
- K211257EFAI PACS Picture Archiving and Communication System2Cleared 510(K)
- K202056Kinepict Medical Imaging Tool 4.02Cleared 510(K)
- K212421ADAS 3D2Cleared 510(K)
- K203696RBknee2Cleared 510(K)
- K211793EzOrtho2Cleared 510(K)
- K211791Ez3D-i/E32Cleared 510(K)
- K210998ROSA Hip System2Cleared 510(K)
- K201573Brain Perfusion (BP) application2Cleared 510(K)
- K212230TruSPECT Radiological Image Processing Station2Cleared 510(K)
- K211863eVolve PACS2Cleared 510(K)
- K212175DynaCAD2Cleared 510(K)
- K212074ClariCT.AI2Cleared 510(K)
- K211655aPROMISE2Cleared 510(K)
- K211279Volpara Imaging Software2Cleared 510(K)
- K211386MySpine WebPlanner & MyBalance2Cleared 510(K)
- K203765ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray2Cleared 510(K)
- K211480NubeX2Cleared 510(K)
- K201835PRE-SURE2Cleared 510(K)
- K210653ONE Planner Hip2Cleared 510(K)
- K2116563D Echo v1.12Cleared 510(K)
- K202718Qmenta Care Platform Family2Cleared 510(K)
- K200704ZedView2Cleared 510(K)
- K211312Universal Viewer2Cleared 510(K)
- K210257Xoran Workstation, Model 100502Cleared 510(K)
- K210187Overjet Dental Assist2Cleared 510(K)
- K202793Cercare Medical Neurosuite2Cleared 510(K)
- K210072HOLOSCOPE-i2Cleared 510(K)
- K210066ImagePilot2Cleared 510(K)
- K210682SOTA Cloud Imaging2Cleared 510(K)
- K202521PtoleMedic System2Cleared 510(K)
- K202084DeepLook PRECISE2Cleared 510(K)
- K210850ADAS 3D2Cleared 510(K)
- K203195Simpleware ScanIP Medical2Cleared 510(K)
- K210071SIS System (Version 5.1.0)2Cleared 510(K)
- K203518Quicktome2Cleared 510(K)
- K203651Cuptimize2Cleared 510(K)
- K203182SubtleMR2Cleared 510(K)
- K202990NinesMeasure2Cleared 510(K)
- K202212TruPlan2Cleared 510(K)
- K200589MyPAO Planning Report2Cleared 510(K)
- K210136PhantomMSK Hip2Cleared 510(K)
- K203312Vitrea Software Package, VSTP-001A2Cleared 510(K)
- K203103Synapse 3D, Synapse 3D Base Tools v6.12Cleared 510(K)
- K203290Bonelogic2Cleared 510(K)
- K203582QUIBIM Precision Prostate (qp-Prostate)2Cleared 510(K)
- K203104IBM iConnect Access2Cleared 510(K)
- K203677ViewPoint 62Cleared 510(K)
- K203142Veuron-Brain-pAb2Cleared 510(K)
- K202847AccuBrain2Cleared 510(K)
- K202414BrainInsight2Cleared 510(K)
- K202229AI Metrics2Cleared 510(K)
- K201250SQuEEZ Software2Cleared 510(K)
- K203249Nucleus.io2Cleared 510(K)
- K202487HealthJOINT2Cleared 510(K)
- K200572Planmeca Romexis2Cleared 510(K)
- K203156DTX Studio Clinic2Cleared 510(K)
- K202805Optimized Positioning System (OPS) Insight2Cleared 510(K)
- K193287CorInsights MRI2Cleared 510(K)
- K203287DBSWIN, VISTAEASY2Cleared 510(K)
- K193306PROView2Cleared 510(K)
- K200750Neuro.Al Algorithm2Cleared 510(K)
- K200350MyHip Planner & Verifier2Cleared 510(K)
- K203058CloudVue2Cleared 510(K)
- K202519OrthoNext Platform System2Cleared 510(K)
- K202948EzOrtho2Cleared 510(K)
- K201710A View LCS2Cleared 510(K)
- K202501Quantib Prostate2Cleared 510(K)
- K200810IPS CaseDesigner2Cleared 510(K)
- K202292UDE2Cleared 510(K)
- K202280Cleerly Labs v2.02Cleared 510(K)
- K201928e-Ortho Shoulder Software2Cleared 510(K)
- K192051THINQ2Cleared 510(K)
- K201103Xeleris V Processing and Review Systems2Cleared 510(K)
- K200603AAA Model2Cleared 510(K)
- K200852EchoPAC Software Only, EchoPAC Plug-In2Cleared 510(K)
- K192890SentEP2Cleared 510(K)
- K201369AVA (Augmented Vascular Analysis)2Cleared 510(K)
- K201665Collaboration Live2Cleared 510(K)
- K202297Aline Ablation Intelligence2Cleared 510(K)
- K2022563Shape Implant Studio2Cleared 510(K)
- K201948AcroDTI Visualizer2Cleared 510(K)
- K202335Ambra ProViewer2Cleared 510(K)
- K200973Synapse 3D Cardiac Tools2Cleared 510(K)
- K200714AVIEW2Cleared 510(K)
- K202116EzDent-i/ E2/ Prora View/ Smart M Viewer2Cleared 510(K)
- K2013523D Auto LAA2Cleared 510(K)
- K201632TOMTEC-ARENA2Cleared 510(K)
- K201232Limbus Contour2Cleared 510(K)
- K200822Braid2Cleared 510(K)
- K201465SuRgical Planner (SRP) BrainStorm2Cleared 510(K)
- K201365True 3D Viewer2Cleared 510(K)
- K193294AI-Rad Companion Engine2Cleared 510(K)
- K201296i-Rapha Solution2Cleared 510(K)
- K201477syngo.via View&GO2Cleared 510(K)
- K193042Optimized Positioning System (OPS) ReView2Cleared 510(K)
- K193290AI-Rad Companion Brain MR2Cleared 510(K)
- K200899Quantib AI Node2Cleared 510(K)
- K192630uWS-MI2Cleared 510(K)
- K201202MI View&GO2Cleared 510(K)
- K192692Brainomix 360 e-CTA2Cleared 510(K)
- K200274CariCloud2Cleared 510(K)
- K201062syngo Ultrasound Apps Suite (sUSAS)2Cleared 510(K)
- K200546ZeeroMED View2Cleared 510(K)
- K200315Ziostation22Cleared 510(K)
- K193220AVIEW LCS2Cleared 510(K)
- K192656Optimized Positioning System (OPS) Insight2Cleared 510(K)
- K193523ArthrexVIP Web Portal2Cleared 510(K)
- K192475NemoFAB2Cleared 510(K)
- K200703JiveX2Cleared 510(K)
- K193369Xelis Dental 2.02Cleared 510(K)
- K200078VARO Plan2Cleared 510(K)
- K200713EchoNavigator2Cleared 510(K)
- K192176IntelePACS2Cleared 510(K)
- K190767AnatomicAligner2Cleared 510(K)
- K192888EzOrtho2Cleared 510(K)
- K190993Kinepict Medical Imaging Tool version v2.22Cleared 510(K)
- K192962icobrain-ctp2Cleared 510(K)
- K200178Ez3D-i /E32Cleared 510(K)
- K192973densitas densityai2Cleared 510(K)
- K200179Collaboration Live2Cleared 510(K)
- K200132Ashvins2Cleared 510(K)
- K192923Vitrea Software Package2Cleared 510(K)
- K192372ASCEND Image Viewer2Cleared 510(K)
- K193498Infinitt RT PACS2Cleared 510(K)
- K192165Acteon Imaging Suite2Cleared 510(K)
- K192462syngo.MR Applications2Cleared 510(K)
- K193261FlightPlan for Embolization2Cleared 510(K)
- K191014Elements Viewer2Cleared 510(K)
- K192098EzMobile2Cleared 510(K)
- K191125ADAS 3D2Cleared 510(K)
- K192917ViewPoint 62Cleared 510(K)
- K192912AutoMIStar2Cleared 510(K)
- K193403UroNav System2Cleared 510(K)
- K193149True 3D Viewer Software2Cleared 510(K)
- K192629Spinalytics2Cleared 510(K)
- K192040AVIEW Modeler2Cleared 510(K)
- K183676DentiqAir2Cleared 510(K)
- K192531QyScore Software2Cleared 510(K)
- K192130Icobrain2Cleared 510(K)
- K192571NemoScan2Cleared 510(K)
- K192279PhantomMSK Trauma2Cleared 510(K)
- K192348SICAT Implant V2.02Cleared 510(K)
- K192038Emprint Visualization Application2Cleared 510(K)
- K192508Medsynapse Ris Pacs & Medsynapse VNA2Cleared 510(K)
- K191278RSI-MRI+2Cleared 510(K)
- K191959QuantX Breast MRI Biopsy Guidance Plugin2Cleared 510(K)
- K191026MEDIP PRO2Cleared 510(K)
- K192109KOALA2Cleared 510(K)
- K190868Cleerly Labs2Cleared 510(K)
- K192743VisionX 2.42Cleared 510(K)
- K183412mediCAD Web2Cleared 510(K)
- K191544Synapse 3D Blood Flow Analysis2Cleared 510(K)
- K192455Merge PACS2Cleared 510(K)
- K191216Voxel Dosimetry™ v1.02Cleared 510(K)
- K190162SmartCeph2Cleared 510(K)
- K191493Ventripoint Medical System Plus (VMS+) 3.02Cleared 510(K)
- K192200DynaCAD2Cleared 510(K)
- K191610RTapp2Cleared 510(K)
- K192435NuVasive NuvaLine2Cleared 510(K)
- K191530StoneChecker2Cleared 510(K)
- K192276Merge Cardio2Cleared 510(K)
- K191688SubtleMR2Cleared 510(K)
- K192304SIS Software Version 3.6.02Cleared 510(K)
- K190780syngo Application Software2Cleared 510(K)
- K183489D2P2Cleared 510(K)
- K183544Efficient Care 3D Planning2Cleared 510(K)
- K183458exoplan 2.32Cleared 510(K)
- K191262aBSI2Cleared 510(K)
- K183193MREplus+ Software2Cleared 510(K)
- K191309syngo.via MI Workflows VB40A, Scenium2Cleared 510(K)
- K191585iNtuition-Structural Heart Module2Cleared 510(K)
- K190694Unifi Workspace v1.0.02Cleared 510(K)
- K182904syngo.MR Applications2Cleared 510(K)
- K190096R2GATE2Cleared 510(K)
- K183170uWS-CT2Cleared 510(K)
- K190913QLAB Advanced Quantification Software 132Cleared 510(K)
- K183460ClariCT.AI2Cleared 510(K)
- K190874Materialise Mimics Enlight2Cleared 510(K)
- K191188ASHK100G2Cleared 510(K)
- K191040syngo.via (Version VB40A)2Cleared 510(K)
- K190764SurgicalAR2Cleared 510(K)
- K190866XmaruView V1 (Xmaru Chiroview, Xmaru Podview)2Cleared 510(K)
- K190042Brainlab Elements Image Fusion Angio2Cleared 510(K)
- K183248Synapse Enterprise Viewer Version 1.02Cleared 510(K)
- K190791Ez3D-i/E32Cleared 510(K)
- K183593Lung Vision System2Cleared 510(K)
- K190420NDOHD High Definition Imaging System (NDOHD)2Cleared 510(K)
- K182572InstaRISPACS / InstaZFP / InstaMobi v5.02Cleared 510(K)
- K190629DBSWIN and VISTAEASY Imaging Software2Cleared 510(K)
- K183210Thoracic VCAR with GSI Pulmonary Perfusion2Cleared 510(K)
- K183105Mimics Medical2Cleared 510(K)
- K190232Synapse PACS2Cleared 510(K)
- K183164uWS-MR2Cleared 510(K)
- K190379MIM on Linux2Cleared 510(K)
- K183019SIS Software version 3.3.02Cleared 510(K)
- K182537RADMAX Digital Imaging Software2Cleared 510(K)
- K182966PLANET Onco Dose2Cleared 510(K)
- K181859Visualase Thermal Therapy System2Cleared 510(K)
- K183478ClearON Mobile2Cleared 510(K)
- K190087EzDent-i / E2 / Prora View2Cleared 510(K)
- K182643IRIS 1.0 System2Cleared 510(K)
- K182332PhantomMSK2Cleared 510(K)
- K190074Presero 3D Scanning System2Cleared 510(K)
- K183272AI Rad Companion (Engine)2Cleared 510(K)
- K183133MRCP+ v1.02Cleared 510(K)
- K182855ProKnow DS2Cleared 510(K)
- K180867AmCAD-UO2Cleared 510(K)
- K182564Quantib ND2Cleared 510(K)
- K182130iSchemaView RAPID2Cleared 510(K)
- K183012vascuCAP2Cleared 510(K)
- K1827504D View2Cleared 510(K)
- K1730413DIEMME RealGUIDE2Cleared 510(K)
- K182624MIM - MRT Dosimetry2Cleared 510(K)
- K182601Vitrea Software Package, VSTP-001A2Cleared 510(K)
- K182419Centricity Universal Viewer2Cleared 510(K)
- K182359HipCheck2Cleared 510(K)
- K182926IntelliSpace Radiology2Cleared 510(K)
- K182016Simplicit90Y2Cleared 510(K)
- K181825CAAS MR Solutions2Cleared 510(K)
- K173083IMPLANTER DENTAL PLANNING SOFTWARE2Cleared 510(K)
- K182815XVWeb 3D2Cleared 510(K)
- K183038Corin Optimized Positioning System (OPS) Plan2Cleared 510(K)
- K183013Vitrea Software Package, VSTP-001A2Cleared 510(K)
- K182431Konicaminolta DI-X12Cleared 510(K)
- K173744ProFuse CAD2Cleared 510(K)
- K181247Vitrea CT Brain Perfusion2Cleared 510(K)
- K172999uWS-MR2Cleared 510(K)
- K173001uWS-CT2Cleared 510(K)
- K181939icobrain2Cleared 510(K)
- K171199AVIEW2Cleared 510(K)
- K173965Implant Planning Software2Cleared 510(K)
- K182464PeekMed2Cleared 510(K)
- K181964JiveX2Cleared 510(K)
- K182561UroNav (Version 3.0)2Cleared 510(K)
- K182034Arterys MICA2Cleared 510(K)
- K181460OnePacs System2Cleared 510(K)
- K181892Ziostation22Cleared 510(K)
- K182290IBM iConnect Access2Cleared 510(K)
- K181773Synapse 3D Optional Tools2Cleared 510(K)
- K180916iNtuition-T1 Mapping and T2/T2* Mapping2Cleared 510(K)
- K182310Volpara Imaging Software2Cleared 510(K)
- K181926InVivo Web Viewer2Cleared 510(K)
- K172418OpenSight2Cleared 510(K)
- K182230Multi Modality Viewer2Cleared 510(K)
- K182208syngo.via View&GO (Version VA10A)2Cleared 510(K)
- K170702mediCAD 4.02Cleared 510(K)
- K180006AmCAD-UT Detection 2.22Cleared 510(K)
- K181185Change Healthcare Enterprise Viewer2Cleared 510(K)
- K180522IGTFusion2Cleared 510(K)
- K181318ONIS-PACS2Cleared 510(K)
- K181962CubeVue2Cleared 510(K)
- K171435VirtuOst Vertebral Fracture Assessment2Cleared 510(K)
- K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer2Cleared 510(K)
- K173444Quantitative Total Extensible Imaging (QTxI)2Cleared 510(K)
- K180629DentiqGuide2Cleared 510(K)
- K173274Ceevra Reveal 2.02Cleared 510(K)
- K173574DenSeeMammo2Cleared 510(K)
- K180815MIM - SPECTRA Quant2Cleared 510(K)
- K172346sterEOS Workstation2Cleared 510(K)
- K181290Fusion Bx 2.02Cleared 510(K)
- K173780EchoMD Automated Ejection Fraction Software2Cleared 510(K)
- K181264QLAB Advanced Quantification Software2Cleared 510(K)
- K181177Interventional Workspot2Cleared 510(K)
- K181080McKesson Cardiology2Cleared 510(K)
- K1808835D Viewer2Cleared 510(K)
- K180641Invenia ABUS Viewer2Cleared 510(K)
- K173390hipEOS2Cleared 510(K)
- K180563syngo.plaza2Cleared 510(K)
- K172768ZOOM2Cleared 510(K)
- K180161Viz CTP2Cleared 510(K)
- K180336syngo.MR Applications2Cleared 510(K)
- K172477iSchemaView RAPID2Cleared 510(K)
- K180549ZED Link2Cleared 510(K)
- K180125PowerLook Density Assessment Software2Cleared 510(K)
- K173897syngo.via MI Workflows2Cleared 510(K)
- K172998uWS-MI2Cleared 510(K)
- K171847Corin Optimized Positioning System (OPS™) Plan2Cleared 510(K)
- K173597Scenium VE20 Software2Cleared 510(K)
- K172239SIMPLANT 182Cleared 510(K)
- K180323Vitrea Software Package; VSTP-001A2Cleared 510(K)
- K173241MED-TAB2Cleared 510(K)
- K180192Emprint Ablation Visualization Application2Cleared 510(K)
- K173619Mimics inPrint2Cleared 510(K)
- K172168WillCeph2Cleared 510(K)
- K180129Imbio Segmentation Editing Tool software2Cleared 510(K)
- K173611syngo Application Software2Cleared 510(K)
- K180262SICAT Endo2Cleared 510(K)
- K180394BrightMatter Plan 1.6.02Cleared 510(K)
- K173939Quantib Brain2Cleared 510(K)
- K180326icobrain2Cleared 510(K)
- K173605iQMR2Cleared 510(K)
- K173312ProBx Software2Cleared 510(K)
- K173145CereMetrix Silver2Cleared 510(K)
- K173863Ez3D-i /E32Cleared 510(K)
- K170540DM-Density2Cleared 510(K)
- K173636Velocity2Cleared 510(K)
- K170793SuRgical Planner (SRP)2Cleared 510(K)
- K180091UNiD Spine Analyzer2Cleared 510(K)
- K162727SENYINT Remote Consultation System2Cleared 510(K)
- K172832Insight BD2Cleared 510(K)
- K172490eUnity2Cleared 510(K)
- K173512MFI-Cardiac2Cleared 510(K)
- K173088Vitrea Software Toshiba Package VSTP-001A2Cleared 510(K)
- K173542Arterys Oncology DL2Cleared 510(K)
- K173622CS Imaging2Cleared 510(K)
- K173054Navigo Workstation Version 2.02Cleared 510(K)
- K173588Illumeo System2Cleared 510(K)
- K172224DTX Studio diagnose2Cleared 510(K)
- K171328cNeuro cMRI2Cleared 510(K)
- K173456ViewPoint 62Cleared 510(K)
- K173420Radiomics App v1.02Cleared 510(K)
- K173467Advanced Diffusion Analysis (ADA) application2Cleared 510(K)
- K173475Merge PACS2Cleared 510(K)
- K172218MIM – Y90 Dosimetry2Cleared 510(K)
- K173378syngo®.via protoNeo (Version VA20)2Cleared 510(K)
- K173329jFit Surgical Planner2Cleared 510(K)
- K171385Planmeca Romexis2Cleared 510(K)
- K173247Surgical Planning Software version 1.12Cleared 510(K)
- K172803Infinitt PACS 7.02Cleared 510(K)
- K173094OrthoVision2Cleared 510(K)
- K171709BR-FHUS Viewer 1.02Cleared 510(K)
- K163623Quantra2Cleared 510(K)
- K173101Curve Image 2.0 PACS2Cleared 510(K)
- K171068OrthoView 7.22Cleared 510(K)
- K172855Vitrea Advanced Visualization, Version 7.62Cleared 510(K)
- K171463ASPIRE Bellus II2Cleared 510(K)
- K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM2Cleared 510(K)
- K1725133D Echo2Cleared 510(K)
- K170981NeuroQuant2Cleared 510(K)
- K172327VMA™ System version 3.02Cleared 510(K)
- K172364EzDent-i / E2 / Prora View2Cleared 510(K)
- K171617OKI Surgical Planning Software2Cleared 510(K)
- K171356Clarity Reveal2Cleared 510(K)
- K171754NovaPACS2Cleared 510(K)
- K163048Smart Stitching Software System, Image Processing, Radiological2Cleared 510(K)
- K170841BiopSee, Mobile US2Cleared 510(K)
- K163232Vitrea View2Cleared 510(K)
- K171544Arterys Viewer2Cleared 510(K)
- K170729Examion X-AQS2Cleared 510(K)
- K1711153D Endo Software2Cleared 510(K)
- K170434Enterprise Imaging XERO Viewer 8.12Cleared 510(K)
- K163668SUITESTENSA2Cleared 510(K)
- K170847EchoPAC Software Only, EchoPAC Plug-in2Cleared 510(K)
- K170747syngo Application Software2Cleared 510(K)
- K171222Vitrea Software Toshiba Package; VSTP-001A2Cleared 510(K)
- K170250SmartTarget2Cleared 510(K)
- K171053syngo Dynamics Version VA302Cleared 510(K)
- K171314QLAB Advanced Quantification Software2Cleared 510(K)
- K162574AmCAD-US2Cleared 510(K)
- K170172UNiD Spine Analyzer2Cleared 510(K)
- K163071vascuCAP2Cleared 510(K)
- K170195QuantX2Cleared 510(K)
- K161601Dynamika2Cleared 510(K)
- K170419SurgiCase Viewer2Cleared 510(K)
- K163622Lung Vision2Cleared 510(K)
- K163250Longitudinal Brain Imaging (LoBI) application2Cleared 510(K)
- K170180Will3D2Cleared 510(K)
- K171130Nucleus Image Management System2Cleared 510(K)
- K163119NaviSuite SSI Edition2Cleared 510(K)
- K162647NuVasive NuvaLine Mobile App2Cleared 510(K)
- K170952syngo.CT View&GO2Cleared 510(K)
- K170069AmCAD-UV2Cleared 510(K)
- K162799Cliniview2Cleared 510(K)
- K170580Carestream Vue PACS2Cleared 510(K)
- K162287Synapse 3D Perfusion Analysis2Cleared 510(K)
- K163076Segment CMR2Cleared 510(K)
- K161341LIFESYS PACS2Cleared 510(K)
- K162559Move Forward 3D Motion Simulation Service2Cleared 510(K)
- K163290INFINITT ULite2Cleared 510(K)
- K163405360KS Implant Positioning System2Cleared 510(K)
- K162868Exam Vue PACS2Cleared 510(K)
- K170451FDX Console (DR-ID300CL) Software2Cleared 510(K)
- K170167True 3D Viewer Software2Cleared 510(K)
- K162484Lung Nodule Assessment and Comparison Option (LNA)2Cleared 510(K)
- K163285syngo Application Software2Cleared 510(K)
- K162830SIS Software2Cleared 510(K)
- K163294syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology2Cleared 510(K)
- K160934UC-CARE NaviGo Workstation2Cleared 510(K)
- K163122NobelClinician, DTX Studio implant2Cleared 510(K)
- K163324nordicBrainEx2Cleared 510(K)
- K162285EBM iDO Viewer 1.2.12Cleared 510(K)
- K163574Multi Modality Viewer2Cleared 510(K)
- K163533EzDent-i; E2; ProraView2Cleared 510(K)
- K161841D2P2Cleared 510(K)
- K163013Quantib Brain 1.22Cleared 510(K)
- K163253Arterys Cardio DL2Cleared 510(K)
- K161270CephSimulation2Cleared 510(K)
- K163421syngo.via MI Workflows2Cleared 510(K)
- K161959ClearView cCAD2Cleared 510(K)
- K163539Ez3D-i / E32Cleared 510(K)
- K162955Multi-Modality Tumor Tracking (MMTT) application2Cleared 510(K)
- K160852Zia2Cleared 510(K)
- K162376CAAS MR 4D Flow2Cleared 510(K)
- K161322CT CoPilot2Cleared 510(K)
- K152009DENSEEMAMMO v1.02Cleared 510(K)
- K163158MEDSYNAPSE Zero Footprint Viewer2Cleared 510(K)
- K162743ViewPoint 62Cleared 510(K)
- K162541syngo Application Software2Cleared 510(K)
- K161515eUnity2Cleared 510(K)
- K161634IPS CaseDesigner2Cleared 510(K)
- K162513Arterys Software v2.02Cleared 510(K)
- K162145vRad PACS with Mammography2Cleared 510(K)
- K162474Artemis2Cleared 510(K)
- K162025IntelliSpace Portal Platform2Cleared 510(K)
- K162011MedDream2Cleared 510(K)
- K160371NovaPACS2Cleared 510(K)
- K161109iSR'obot MRI-US Fusion2Cleared 510(K)
- K160666Dentiq3D2Cleared 510(K)
- K161828kneeEOS2Cleared 510(K)
- K162339Scenium2Cleared 510(K)
- K162112CAAS MRV2Cleared 510(K)
- K161625PixelShine2Cleared 510(K)
- K162008JiveX2Cleared 510(K)
- K162141Restore PACS2Cleared 510(K)
- K153705PROcedure Rehearsal Studio2Cleared 510(K)
- K161130ResolutionMD2Cleared 510(K)
- K161518PACS CORE/ENCORE2Cleared 510(K)
- K152949WebPAX2Cleared 510(K)
- K1619555D Viewer2Cleared 510(K)
- K161148icobrain2Cleared 510(K)
- K161113QXLink2Cleared 510(K)
- K160284JointPoint2Cleared 510(K)
- K160937Senolris2Cleared 510(K)
- K161382LVivo Software Application2Cleared 510(K)
- K161118SIMPLANT Online Case Review and SIMPLANT Editor2Cleared 510(K)
- K161419Multi Modality Viewer2Cleared 510(K)
- K161685syngo®.via protoNeo (Version VA10A)2Cleared 510(K)
- K161479hipEOS2Cleared 510(K)
- K160584Surgical Navigation Advanced Platform (SNAP)2Cleared 510(K)
- K161559Kuvia3D2Cleared 510(K)
- K161061IMPAX Volume Viewing 4.02Cleared 510(K)
- K161444DBSWIN and VistaEasy Imaging Software2Cleared 510(K)
- K160334Advanced Medical Imaging Software Suite (KSWVWR)2Cleared 510(K)
- K153351Quantib Brain 12Cleared 510(K)
- K161188HEPATIQ 1.12Cleared 510(K)
- K161246Ez3D-i / E32Cleared 510(K)
- K1537363mensio Workstation2Cleared 510(K)
- K161117EzDent-i / E2 / Prora View2Cleared 510(K)
- K151913MIM-Thin Client (mobile)2Cleared 510(K)
- K160914sterEOS Workstation2Cleared 510(K)
- K153653DICOM Viewer2Cleared 510(K)
- K160376EndoSize2Cleared 510(K)
- K160579Xmaru View V1 and Xmaru PACS, Medical Image Processing Software2Cleared 510(K)
- K160407spineEOS2Cleared 510(K)
- K153284Synaptive ImageDrive Pro2Cleared 510(K)
- K152716EV Insite System2Cleared 510(K)
- K160150Vitrea CT Colon Analysis2Cleared 510(K)
- K153355Xeleris 4.0 Processing and Review Workstation2Cleared 510(K)
- K153612ArthrexVIP Web Portal2Cleared 510(K)
- K160426syngo.via MI Workflows2Cleared 510(K)
- K153346syngo Application Software VD112Cleared 510(K)
- K152602Olea Sphere V3.02Cleared 510(K)
- K160317syngo.via MI Workflows2Cleared 510(K)
- K153091IMPLANT 3D2Cleared 510(K)
- K151737MedicVOD System2Cleared 510(K)
- K152034FS-PACS2Cleared 510(K)
- K160315I4 (Integrated Intelligent Imaging Informatics) system2Cleared 510(K)
- K143290DBSWIN and VistaEasy Imaging Software2Cleared 510(K)
- K153593CliniscanSM MRI2Cleared 510(K)
- K160001TraumaCad Mobile Release 2.02Cleared 510(K)
- K153103CARESTREAM Vue PACS2Cleared 510(K)
- K160108Synapse PACS2Cleared 510(K)
- K153166Fusion Bx2Cleared 510(K)
- K152977DG PACS2Cleared 510(K)
- K152352Stereo 3D option for Vision Applications2Cleared 510(K)
- K153289HEALTHMYNE2Cleared 510(K)
- K151075BR-ABVS Viewer 1.02Cleared 510(K)
- K151152ImplantMax Software2Cleared 510(K)
- K153427Volpara Imaging Software2Cleared 510(K)
- K152746Ez3D Plus2Cleared 510(K)
- K152172Econsole12Cleared 510(K)
- K152078Implant Studio 20152Cleared 510(K)
- K152822VidiStar HeartView2Cleared 510(K)
- K153022Philips IntelliSpace Cardiovascular2Cleared 510(K)
- K153073UroNav (Version 2.0)2Cleared 510(K)
- K152661HICAT Air2Cleared 510(K)
- K151212Ziostation22Cleared 510(K)
- K152028Volpara Imaging Software2Cleared 510(K)
- K151988Visible Patient Suite2Cleared 510(K)
- K151941DEXIS Webview2Cleared 510(K)
- K151501OrthoVis Web Portal2Cleared 510(K)
- K151774CARESTREAM Vue Motion2Cleared 510(K)
- K143586FACT Medical Imaging Sysytem2Cleared 510(K)
- K151957BOX DICOM Viewer2Cleared 510(K)
- K152186HealthMyne PACS2Cleared 510(K)
- K151837CS 3D Imaging2Cleared 510(K)
- K151371Corporate Dental Imaging (CDI) Application2Cleared 510(K)
- K151859Synapse Cardiovascular2Cleared 510(K)
- K151850McKesson Cardiology2Cleared 510(K)
- K151353syngo.MR Neurology, syngo.MR Oncology2Cleared 510(K)
- K151687QuantorView2Cleared 510(K)
- K151568Arthrex OrthoVis Preoperative Plan2Cleared 510(K)
- K1518083D/5D Viewer2Cleared 510(K)
- K143368GenIQ2Cleared 510(K)
- K1518543MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display2Cleared 510(K)
- K143176UltraLinq2Cleared 510(K)
- K151091Vitrea Software Toshiba Package, VSTP-001A2Cleared 510(K)
- K150313Ablation Confirmation2Cleared 510(K)
- K151438Dentrix Ascend Imaging2Cleared 510(K)
- K142750JiveX2Cleared 510(K)
- K151192syngo.via MI Workflows2Cleared 510(K)
- K150415NilRead2Cleared 510(K)
- K150761Ez3D-i/E32Cleared 510(K)
- K150976Collage2Cleared 510(K)
- K151115MR Core Software2Cleared 510(K)
- K143397ICIS View2Cleared 510(K)
- K150707IntelePACS2Cleared 510(K)
- K150420Centricity Universal Viewer2Cleared 510(K)
- K150069Fine Structure Analysis(fineSA)2Cleared 510(K)
- K142648SPINEDESIGN Spine Surgery Planning (Software Application)2Cleared 510(K)
- K142196Visage Ease Pro2Cleared 510(K)
- K150843syngo®.via (version VB10A)2Cleared 510(K)
- K142779SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED2Cleared 510(K)
- K142647mint Lesion2Cleared 510(K)
- K150738VitreaView2Cleared 510(K)
- K150747EzDent-i /E2/Prora View2Cleared 510(K)
- K150192Scenium2Cleared 510(K)
- K143361Mammo Workstation2Cleared 510(K)
- K150193Customer Remote Console (CRC)2Cleared 510(K)
- K142337Blackford Analysis Registration Product Family2Cleared 510(K)
- K143318DR Systems Zero Download 3D Viewer (Z3D)2Cleared 510(K)
- K141536VIEWING CLIENT MOBILE2Cleared 510(K)
- K150258Vitrea, Version 7.0 Medical Image Processing Software2Cleared 510(K)
- K142923TraumaCad Mobile Release 1.02Cleared 510(K)
- K150085GE EchoPAC2Cleared 510(K)
- K143319Syngo X-workplace SW VD102Cleared 510(K)
- K150122TOMTEC-ARENA TTA22Cleared 510(K)
- K143044CAAS A-Valve2Cleared 510(K)
- K140828NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE2Cleared 510(K)
- K142107ECHO TRUE 3D VIEWER2Cleared 510(K)
- K141561VM PACS WITH VM MEDICAL WORKSTATION2Cleared 510(K)
- K142850McKesson Radiology Mammography Plus2Cleared 510(K)
- K142316IMPAX Agility2Cleared 510(K)
- K140587MR-CT VVA2Cleared 510(K)
- K142514UniWeb 8.02Cleared 510(K)
- K142891HEPATIQ2Cleared 510(K)
- K142944ArthroPlan Digital Templating Software2Cleared 510(K)
- K142919EXA2Cleared 510(K)
- K140860ImmersiveTouch3 and MicrovisTouch2Cleared 510(K)
- K140797IPACS MEDICAL IMAGE MANAGEMENT SYSTEM2Cleared 510(K)
- K143254eSie Apps Suite2Cleared 510(K)
- K142671ONEFIT HIP PLANNER2Cleared 510(K)
- K143079Endovascular Stent Planning Software2Cleared 510(K)
- K142521Synapse 3D Liver and Kidney Analysis2Cleared 510(K)
- K141881RAPIDRESULTS2Cleared 510(K)
- K141745IQQA-BODYIMAGING SOFTWARE2Cleared 510(K)
- K141570IMPLANT STUDIO2Cleared 510(K)
- K132853NOVAPACS2Cleared 510(K)
- K142037QUANTRA2Cleared 510(K)
- K141669SURGIMAP2Cleared 510(K)
- K141607DENTAL IMAGING SOFTWARE2Cleared 510(K)
- K140399EBM IDO VIEWER2Cleared 510(K)
- K142048EMPRINT PROCEDURE PLANNING APPLICATION2Cleared 510(K)
- K141137STEREOS WORKSTATION2Cleared 510(K)
- K141514SYNAPSE 3D TENSOR ANALYSIS2Cleared 510(K)
- K141364CLIMB MAMMOGRAPHY VIEWER SOFTWARE2Cleared 510(K)
- K141451VixWin Platinum2Cleared 510(K)
- K141480CVI422Cleared 510(K)
- K131348ORTOMED2Cleared 510(K)
- K141302VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)2Cleared 510(K)
- K141061REMOTEYE VIEWER2Cleared 510(K)
- K141475ENDOSIZE2Cleared 510(K)
- K140897SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL2Cleared 510(K)
- K141554ESIE APPS SUITE2Cleared 510(K)
- K140869DCAS I2Cleared 510(K)
- K141556AVREO INTERWORKS SYSTEM2Cleared 510(K)
- K140909MCKESSON RADIOLOGY2Cleared 510(K)
- K140819SURGICAL NAVIGATION ADVANCED PLATFORM2Cleared 510(K)
- K141329RADSPA2Cleared 510(K)
- K141199QUENTRY DOSE REVIEW2Cleared 510(K)
- K140713PLANMECA ROMEXIS2Cleared 510(K)
- K140960PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM2Cleared 510(K)
- K133098SENYINT PACS2Cleared 510(K)
- K140434MEDICAD CLASSIC2Cleared 510(K)
- K140337BRIGHTMATTER PLANNING SOFTWARE2Cleared 510(K)
- K140139CLEARVIEWHD2Cleared 510(K)
- K132684MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO)2Cleared 510(K)
- K140395VITREA IMAGE DENOISING SOFTWARE2Cleared 510(K)
- K140445DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC2Cleared 510(K)
- K140808Q-STATION2Cleared 510(K)
- K133521AZE PHOENIX SOFTWARE2Cleared 510(K)
- K133910NORDICBRAINEX2Cleared 510(K)
- K140271TABLET VIEWER SOFTWARE FOR IMAGE SUITE2Cleared 510(K)
- K133984CORONIS 5MP2Cleared 510(K)
- K133508RESOLUTIONMD MOBILE2Cleared 510(K)
- K133663NIO COLOR 2MP2Cleared 510(K)
- K133401SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL2Cleared 510(K)
- K140093TABLE2Cleared 510(K)
- K133135IMPAX VOLUME VIEWING 3.02Cleared 510(K)
- K133966MODEL-BASED RSA SOFTWARE2Cleared 510(K)
- K133022ZEDVIEW2Cleared 510(K)
- K133937HEARTSCAN SOFTWARE2Cleared 510(K)
- K133654SCENIUM2Cleared 510(K)
- K133609THE DOME S6C2Cleared 510(K)
- K132763ADVANCED VIEWER2Cleared 510(K)
- K140033TARGET3D FUSION2Cleared 510(K)
- K133385LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE2Cleared 510(K)
- K133644SYNGO.VIA MI WORKFLOWS2Cleared 510(K)
- K133320SICAT FUNCTION2Cleared 510(K)
- K14021430.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6)2Cleared 510(K)
- K1401083MP COLOR LCD DISPLAY2Cleared 510(K)
- K1401033MP GRAYSCAKE LCD DISPLAY2Cleared 510(K)
- K133708MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR2Cleared 510(K)
- K132824CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION2Cleared 510(K)
- K1340026MP COLOR LCD MONITOR, RADIFORCE RX6502Cleared 510(K)
- K133730CO PILOT/REGIUS UNITEA2Cleared 510(K)
- K132770DOME S102Cleared 510(K)
- K133030DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)2Cleared 510(K)
- K132499ICRCO CLARITY VIEWER2Cleared 510(K)
- K133875THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA2Cleared 510(K)
- K13368621.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)2Cleared 510(K)
- K130998SYNGO.VIA WEB VIEWER2Cleared 510(K)
- K132095OLEA SPHERE2Cleared 510(K)
- K131447INTUITION - TDA, TVA, PARAMETRIC MAPPING2Cleared 510(K)
- K133367ORTHOVIS PREOPERATIVE PLAN2Cleared 510(K)
- K132342XVWEB2Cleared 510(K)
- K13351121.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025)2Cleared 510(K)
- K132963FUSIONSYNC, CHIMAERA FUSIONSYNC2Cleared 510(K)
- K132773SIDEXIS 42Cleared 510(K)
- K132532SYNGO.PLAZA VB10A2Cleared 510(K)
- K13318121.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)2Cleared 510(K)
- K13318521.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358)2Cleared 510(K)
- K132742M-VU BREAST DENSITY2Cleared 510(K)
- K131390JUSHA-M52C MEDICAL DISPLAY2Cleared 510(K)
- K133357CHARRUAPACS SYSTEM2Cleared 510(K)
- K132544TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA2Cleared 510(K)
- K132799CLARISO PACS2Cleared 510(K)
- K132586PAXERAPACS2Cleared 510(K)
- K132316MULTIVIEW2Cleared 510(K)
- K132188MAMMOGRAPHY VIEWER SMV6582Cleared 510(K)
- K132636DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM2Cleared 510(K)
- K121447ISCHEMA VIEW RAPID2Cleared 510(K)
- K122536AMCAD-UT DETECTION MODEL 2.02Cleared 510(K)
- K131873NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)2Cleared 510(K)
- K131685GE ECHOPAC2Cleared 510(K)
- K131977CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT2Cleared 510(K)
- K132302QXLINK2Cleared 510(K)
- K131389JUSHA-C31 MEDICAL DISPLAY2Cleared 510(K)
- K123944KOSTEC MEDICAL GRADE LDC MONITORS2Cleared 510(K)
- K1326105MP GRAYSCALE LCD DISPLAY2Cleared 510(K)
- K132587MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR2Cleared 510(K)
- K131594EZDENTI-I; E2; PRORA VIEW2Cleared 510(K)
- K131616EZ3D-I, E32Cleared 510(K)
- K130374OMNI-VUE 2 SYSTEM2Cleared 510(K)
- K130242MAVEN PRO2Cleared 510(K)
- K131391JUSHA-M32 MEDICAL DISPLAY2Cleared 510(K)
- K131158CORVIEW2Cleared 510(K)
- K130749SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR2Cleared 510(K)
- K131570ORTHOVISION2Cleared 510(K)
- K130779LVIVO EF SYSTEM2Cleared 510(K)
- K132165QLAB QUANTIFICATION SOFTWARE2Cleared 510(K)
- K130743THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL2Cleared 510(K)
- K1314483D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION2Cleared 510(K)
- K131498IQQA-LIVER MULTIMODALITY SOFTWARE2Cleared 510(K)
- K132062ESIE APPS SUITE2Cleared 510(K)
- K131822ULTRAEXTEND USWS-900A V2.1 AND V3.12Cleared 510(K)
- K13113721.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)2Cleared 510(K)
- K131424MIPLATFORM MEDICAL IMAGING SUITE2Cleared 510(K)
- K1310902MP COLOR LCD MONITOR, RADIFORCE MX2152Cleared 510(K)
- K130724CODIAGNOSTIX IMPLANT PLANNING SOFTWARE2Cleared 510(K)
- K130542SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS2Cleared 510(K)
- K131392ETIAM PACS COMPONENTS2Cleared 510(K)
- K131295NIO COLOR 3MP LED2Cleared 510(K)
- K130278MR PERMEABILITY2Cleared 510(K)
- K131246CORONIS 3MP2Cleared 510(K)
- K131299ANYTHINK PACS WORKSTATION2Cleared 510(K)
- K123306NORDIC TUMOREX2Cleared 510(K)
- K124051THE VAULT SYSTEM2Cleared 510(K)
- K1311184D VIEW2Cleared 510(K)
- K123082MOBILECT VIEWER2Cleared 510(K)
- K130159QLAB QUANTIFICATION SOFTWARE HEART MODEL2Cleared 510(K)
- K130624CONI2Cleared 510(K)
- K130770MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR2Cleared 510(K)
- K130772MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR2Cleared 510(K)
- K130929ZMED VP40002Cleared 510(K)
- K130884XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION2Cleared 510(K)
- K130383SYNAPSE 3D CARDIAC TOOLS2Cleared 510(K)
- K130069INNOVA EPVISION 2.0, INNOVA EPVISION 2.02Cleared 510(K)
- K121916INTUITION2Cleared 510(K)
- K1303365MP MONOCHROME LCD MONITOR, RADIFORCE GX5402Cleared 510(K)
- K123976NOBELCLINICIAN2Cleared 510(K)
- K130393MIRADA RTX2Cleared 510(K)
- K130228SUITEHEART2Cleared 510(K)
- K123186RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-312Cleared 510(K)
- K130395STEREOS WORKSTATION2Cleared 510(K)
- K123426MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS2Cleared 510(K)
- K122578VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING2Cleared 510(K)
- K123650ARIX RAD ACQUISITION CONSOLE2Cleared 510(K)
- K123575MAMMOWORKSTATION2Cleared 510(K)
- K120851COMMUNIFY PACS VIEWER2Cleared 510(K)
- K130103CORONIS FUSION 6MP2Cleared 510(K)
- K1300704MP COLOR LCD MONITOR, RADIFORCE RX4402Cleared 510(K)
- K123023SURGERY REHEARSAL PLATFORM2Cleared 510(K)
- K123970CAAS INTRAVASCULAR2Cleared 510(K)
- K123519INVIVO DENTAL2Cleared 510(K)
- K123420SYNGO, BREAST CARE2Cleared 510(K)
- K124048IMAGEQUBE2Cleared 510(K)
- K123894GE ECHOPAC2Cleared 510(K)
- K123901TRACTUS TISSUEMAPPER REVIEWER APPLICATION2Cleared 510(K)
- K123269PROCEDURE REHEARSAL STUDIO2Cleared 510(K)
- K123577SYNGO.VIA MI WORKFLOWS2Cleared 510(K)
- K123566SYNAPSE 3D COLON ANALYSIS2Cleared 510(K)
- K123920SYNGO.VIA2Cleared 510(K)
- K121762CARDIAC VX2Cleared 510(K)
- K123922SYNGO DYNAMICS2Cleared 510(K)
- K123302IB CLINIC2Cleared 510(K)
- K121296INTERVENTIONAL WORKSPOT2Cleared 510(K)
- K123526CLEARREAD +CONFIRM2Cleared 510(K)
- K123530MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)2Cleared 510(K)
- K123528SCENIUM2Cleared 510(K)
- K120995ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT2Cleared 510(K)
- K122429VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL2Cleared 510(K)
- K123375SYNGO.VIA2Cleared 510(K)
- K123174CENTRICITY PACS-IW WITH UNIVERSAL VIEWER2Cleared 510(K)
- K113344STEREOS WORKSTATION2Cleared 510(K)
- K121213VITREAADVANCED2Cleared 510(K)
- K121200FLIGHTPLAN FOR LIVER2Cleared 510(K)
- K121781ECHONAVIGATOR RELEASE 12Cleared 510(K)
- K122289IMAGE-COM 5.02Cleared 510(K)
- K122523CARESTREAM VUE PACS2Cleared 510(K)
- K121076ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE2Cleared 510(K)
- K122843MD211G3 21.3 DIAGNOSTIC IMAGING LCD MONITOR2Cleared 510(K)
- K122022ATHEROEDGE2Cleared 510(K)
- K111142ECHOSOFT(TM)2Cleared 510(K)
- K120288ORTHOCAD SOFTWARE OPTION2Cleared 510(K)
- K122427CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE2Cleared 510(K)
- K122260AYCAN MOBILE2Cleared 510(K)
- K122164MR VESSELLQ XPRESS2Cleared 510(K)
- K122136VITREAVIEW2Cleared 510(K)
- K122329BIOJET2Cleared 510(K)
- K122205EXINI2Cleared 510(K)
- K1204518MP COLOR LCD MONITOR, REDIFORCE RX8402Cleared 510(K)
- K120734MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE2Cleared 510(K)
- K121292DYNAPBV BODY SOFTWARE2Cleared 510(K)
- K121075NERVEVISION SOFTWARE SYSTEMS2Cleared 510(K)
- K121788NIO 5MP2Cleared 510(K)
- K121517VERSAVUE ENTERPRISE SUITE2Cleared 510(K)
- K1135623MP COLOR LCD MONITOR, RADIFORCE RX3402Cleared 510(K)
- K113620MYRIAN 1.112Cleared 510(K)
- K121449DIRECTPATH2Cleared 510(K)
- K120305THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV2Cleared 510(K)
- K120733SIMPLANT GO2Cleared 510(K)
- K120636SYNAPSE 3D CARDIAC TOOLS2Cleared 510(K)
- K120514CARDIOPACS2Cleared 510(K)
- K121459SYNGO.MR NEUROLOGY2Cleared 510(K)
- K120472QUANTRA2Cleared 510(K)
- K113456READY VIEW2Cleared 510(K)
- K120648SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS2Cleared 510(K)
- K121074SCENIUM 2.02Cleared 510(K)
- K121387CENTRICITY PACS-IW2Cleared 510(K)
- K120679SYNAPSE 3D NODULE ANALYSIS2Cleared 510(K)
- K121466GUIDEMIA2Cleared 510(K)
- K121023SPECTRUM V.02Cleared 510(K)
- K113739SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM2Cleared 510(K)
- K121223QLAB WITH FHN AND VPQ PLUG-IN2Cleared 510(K)
- K120637SYNAPSE 3D BRAIN PERFUSION2Cleared 510(K)
- K113599SURGICASE CONNECT2Cleared 510(K)
- K120207VISIA2Cleared 510(K)
- K1132403.7 MP COLOR LCD MONITOR, RADIFORCE MX270W2Cleared 510(K)
- K120718INSTAPACS/INSTARISPACS2Cleared 510(K)
- K1204072MP MONOCHROME LCD MONITOR, RADIFORCE GX2402Cleared 510(K)
- K120196OLEA SPHERE2Cleared 510(K)
- K120076RESOLUTIONMD WEB2Cleared 510(K)
- K1203673MENSIO WORKSTATION2Cleared 510(K)
- K120315SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION2Cleared 510(K)
- K120161ALPHAPOINT IMAGING SOFTWARE2Cleared 510(K)
- K1201352D CARDIAC PERFORMANCE ANALYSIS MR 1.02Cleared 510(K)
- K120709THE DOME GX4MP COLOR NONITOR2Cleared 510(K)
- K120361SYNAPSE 3D BASE TOOLS2Cleared 510(K)
- K120187MULTI-MODALITY IMAGE FUSION2Cleared 510(K)
- K120221GE ECHOPAC2Cleared 510(K)
- K120484VISIA ONCOLOGY2Cleared 510(K)
- K120115ORTHOSIZE2Cleared 510(K)
- K120525QLAB QUANTIFICATION SOFTWARE2Cleared 510(K)
- K113082SONOVISION2Cleared 510(K)
- K1137843MP MONOCHROME LCD MONITOR, RADIFORCE GX3402Cleared 510(K)
- K113844RADIFORCE RX2402Cleared 510(K)
- K112807X-RAY VVA2Cleared 510(K)
- K112679SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM2Cleared 510(K)
- K113701VISIA NEURO2Cleared 510(K)
- K1134423DI2Cleared 510(K)
- K113419CS IMAGING2Cleared 510(K)
- K111758CADENS (TM) COLON2Cleared 510(K)
- K113076CAAS A-VALVE2Cleared 510(K)
- K112720MCKESSON HORIZON CARDIOLOGY2Cleared 510(K)
- K111385DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE2Cleared 510(K)
- K112251SWISSMEDA DENTAL PLANNING SYSTEM2Cleared 510(K)
- K112008TOUCHPACS SUITE2Cleared 510(K)
- K111861SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE2Cleared 510(K)
- K111776DELTAVIEW MODEL 2.12Cleared 510(K)
- K112387PROCEDURE REHEARSAL STUDIO(TM)2Cleared 510(K)
- K11344321.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)2Cleared 510(K)
- K113244SYNAPSE MPR FUSION2Cleared 510(K)
- K112109THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE2Cleared 510(K)
- K11313621.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)2Cleared 510(K)
- K103554METRON-CP/MD2Cleared 510(K)
- K1132268MP COLOR LCD MONITOR,RADIFORCE RX8402Cleared 510(K)
- K113541CLEARSTART SVM SYSTEM2Cleared 510(K)
- K113543ONDEMAND3D2Cleared 510(K)
- K112480VIEW 1 IMAGING2Cleared 510(K)
- K113404DENTAL 3D PLANNING SOFTWARE2Cleared 510(K)
- K112930MOBILE MIM2Cleared 510(K)
- K112570CENTRICITY CARDIO IMAGING2Cleared 510(K)
- K1123545MP MONOCHROME LCD MONITOR, RADIFORCE GX5302Cleared 510(K)
- K113029SYNGO VIA MI WORKFLOWS2Cleared 510(K)
- K112531VITREA CT MYOCARDIAL ANALYSIS2Cleared 510(K)
- K111642ONCO TRAC MODEL 1, 2, 42Cleared 510(K)
- K110596MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM2Cleared 510(K)
- K112145MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I22Cleared 510(K)
- K111161PERFSCAPE V2.02Cleared 510(K)
- K110765FXA (TM)2Cleared 510(K)
- K100784UC-CARE NAVIGO SYTEM2Cleared 510(K)
- K11260421.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)2Cleared 510(K)
- K1124664MP COLOR LCD MONITOR, RADIFORCERX4302Cleared 510(K)
- K112974PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM2Cleared 510(K)
- K110919CARESTREAM PACS2Cleared 510(K)
- K112439SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.02Cleared 510(K)
- K111990CORONIS 5MP2Cleared 510(K)
- K112051LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE2Cleared 510(K)
- K1125303DI INCLUDING CSCORE2Cleared 510(K)
- K112096IMAGELINK2Cleared 510(K)
- K111019SURGIMAP (TM) SPINE2Cleared 510(K)
- K111641SURGICASE ORTHOGNATHIC SOFTWARE WIZARD2Cleared 510(K)
- K11149621.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR2Cleared 510(K)
- K111989CORONIS FUSION 4MP DL2Cleared 510(K)
- K111833VIRTUE2Cleared 510(K)
- K111731MOLECULAR BREAST IMAGING SOFTWARE2Cleared 510(K)
- K111694ASTRA2Cleared 510(K)
- K110033FEEL-DRCS2Cleared 510(K)
- K101898R4 ACERT ULTRASOUND REPORTING SYSTEM2Cleared 510(K)
- K111660XELIS CARDIAC2Cleared 510(K)
- K111346RESOLUTIONMD MOBILE MODEL RMB-MOB-2X2Cleared 510(K)
- K111613XELIS FUSION2Cleared 510(K)
- K103308AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE2Cleared 510(K)
- K103181ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM2Cleared 510(K)
- K111373CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE2Cleared 510(K)
- K111991NIO COLOR 2MP2Cleared 510(K)
- K102078RADIOLOGICAL IMAGE PROCESSING SYSTEM2Cleared 510(K)
- K111945IMPAX NEXT GENERATION2Cleared 510(K)
- K111319IBIS EXPLORER AND MARKUP SOFTWARE2Cleared 510(K)
- K111245HEARTNAVIGATOR RELEASE 12Cleared 510(K)
- K111892VITREAVIEW SOFTWARE 6.12Cleared 510(K)
- K111804INTELLISPACE PACS 4.X2Cleared 510(K)
- K111222MRI-Q SYSTEM2Cleared 510(K)
- K103130XELIS 3D2Cleared 510(K)
- K110797COMMUNIFY PACS VIEWER2Cleared 510(K)
- K110300SIMPLANT 20112Cleared 510(K)
- K110886CLIO/CLIOSOFT2Cleared 510(K)
- K111638IMPAX VOLUME VIEWING2Cleared 510(K)
- K110414QLAB 8.1 QUANTIFICATION SOFTWARE2Cleared 510(K)
- K111237MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY2Cleared 510(K)
- K10372410 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030)2Cleared 510(K)
- K110447ECHOINSIGHT2Cleared 510(K)
- K111336EBW NM 2.02Cleared 510(K)
- K102534AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE2Cleared 510(K)
- K111052SYNGO NEURO PBV-IR2Cleared 510(K)
- K103723SICAT IMPLANT V1.22Cleared 510(K)
- K111079SYNGO.VIA WEB VIEWER2Cleared 510(K)
- K110430DOLPHIN IMAGING2Cleared 510(K)
- K111164EUNITY2Cleared 510(K)
- K111102RADIOVISION2Cleared 510(K)
- K110875CENTRICITY PACS2Cleared 510(K)
- K110573READY VIEW2Cleared 510(K)
- K110834AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION2Cleared 510(K)
- K111024JETPACK 2.02Cleared 510(K)
- K110139CURVE IMAGE2Cleared 510(K)
- K110844SYMBIA.NET2Cleared 510(K)
- K103565MEDVOXEL HEARTPRO SOFTWARE APPLICATION2Cleared 510(K)
- K110667IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS2Cleared 510(K)
- K1105954D SONO-SCAN 1.02Cleared 510(K)
- K110186SYNAPSE 3D LIVER ANALYSIS2Cleared 510(K)
- K110494SYNGO MBF2Cleared 510(K)
- K110332CLEARCANVAS RIS / PACS2Cleared 510(K)
- K103546AYCAN WORKSTATION OSIRIX PRO2Cleared 510(K)
- K110108MODALIXX2Cleared 510(K)
- K103720SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS2Cleared 510(K)
- K110511E4D COMPASS2Cleared 510(K)
- K103480THORACIC VCAR2Cleared 510(K)
- K103792BARCO MAMMO TOMOSYNTHESIS2Cleared 510(K)
- K103687SYNAPSE 3D CEREBRAL ANALYSIS2Cleared 510(K)
- K103458VIEWPOINT 62Cleared 510(K)
- K103679AXIS PACS, HMS PACS2Cleared 510(K)
- K103576MIM 5.2 (BRACHY)2Cleared 510(K)
- K103761VISUALIZE: VASCULAR2Cleared 510(K)
- K103785MOBILE MIM2Cleared 510(K)
- K101842ACIES2Cleared 510(K)
- K101398STEREOS WORKSTATION2Cleared 510(K)
- K103385SECURVIEW DX DIAGNOSTIC WORKSTATION2Cleared 510(K)
- K110071COR ANALYZER2Cleared 510(K)
- K103465SYNAPSE 3D CARDIAC TOOLS2Cleared 510(K)
- K110077NEUCOLONCARE2Cleared 510(K)
- K110040OMNIVISION2Cleared 510(K)
- K103815Q-STATION2Cleared 510(K)
- K103182TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM2Cleared 510(K)
- K103475SPINEANALYER MODEL SAPOC2Cleared 510(K)
- K100372SAFECT MODEL VER 1.02Cleared 510(K)
- K100837PACENTRIC CONNECT, TRAVELER AND WEB2Cleared 510(K)
- K102849ACCULMAING2Cleared 510(K)
- K09272820.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A)2Cleared 510(K)
- K101654IMPROVIS IMAGING SYSTEM2Cleared 510(K)
- K101707FULACCESS MODEL 1.02Cleared 510(K)
- K102435BEYONDIMAGE WORKSTATION2Cleared 510(K)
- K102000IMAGYS2Cleared 510(K)
- K102556VOLPARA, VERSION 1.32Cleared 510(K)
- K1011664D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ2Cleared 510(K)
- K102150SYNGO DYNAMICS, VERSION 9.02Cleared 510(K)
- K101324GE ECHOPAC MODEL BT102Cleared 510(K)
- K102687MIRADA RT2Cleared 510(K)
- K102684XELIS DENTAL2Cleared 510(K)
- K101311EP NAVIGATOR R32Cleared 510(K)
- K101697ENSITE VERISMO SEGMENTATION TOOL V.2.02Cleared 510(K)
- K100793UROSTATION 3D PROSTATE SUITE2Cleared 510(K)
- K101342OSIRIX MD2Cleared 510(K)
- K093269PROCEDURE REHEARSAL STUDIO2Cleared 510(K)
- K102148CURIEPACS (DICOM PACS SOFTWARE)2Cleared 510(K)
- K101749SYNGO TRUED SOFTWARE2Cleared 510(K)
- K09094721.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)2Cleared 510(K)
- K101666SYNGO. PLAZA VA20A2Cleared 510(K)
- K101279CORRIDOR4DM V2010 MODEL: V20102Cleared 510(K)
- K101662SYNAPSE 3D BASIC TOOLS2Cleared 510(K)
- K092328MED-SEG, MODEL BTMS 10002Cleared 510(K)
- K101796PACSMATE MMD-5201M MONITOR2Cleared 510(K)
- K101228MIRADA XD2Cleared 510(K)
- K093197CORONIS FUSION 10MP, MODEL MDCG-101302Cleared 510(K)
- K092915CEDARA WEBACCESS, MODEL: 2.42Cleared 510(K)
- K100619SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 105208272Cleared 510(K)
- K100292CAAS QVA 3D, CAAS QCA 3D2Cleared 510(K)
- K094064ILUMA VISION MODEL VERSION 2.22Cleared 510(K)
- K100881SYNAPSE OBLIQUUS MIP/MPR/FUSION2Cleared 510(K)
- K100335ORS VISUAL2Cleared 510(K)
- K100236STAIR SYSTEMS PACS & DICOM VIEWER2Cleared 510(K)
- K093603STORM-BASE 2.02Cleared 510(K)
- K092363SOFTVIEW, MODEL 2.012Cleared 510(K)
- K091631ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW2Cleared 510(K)
- K092427SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION)2Cleared 510(K)
- K100094CARESTREAM IMAGE SUITE2Cleared 510(K)
- K093480CUATTRO UNOMD2Cleared 510(K)
- K090050STEREOS WORKSTATION2Cleared 510(K)
- K093612SYNGO.PLAZA2Cleared 510(K)
- K092613COLOR LCD MONITOR, MODEL RADIFORCE RS2102Cleared 510(K)
- K092842ECHOPLAQUE2Cleared 510(K)
- K093621SYNGO.PET&CT ONCOLOGY2Cleared 510(K)
- K093444EXAPACS2Cleared 510(K)
- K0937033DI2Cleared 510(K)
- K093982XELERIS 3 PROCESSING AND REVIEW WORKSTATION2Cleared 510(K)
- K093355PCR ELEVA 1.22Cleared 510(K)
- K093090GALILEOS IMPLANT, VERSION 1.72Cleared 510(K)
- K093672AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION2Cleared 510(K)
- K093117DIGITAL LIGHTBOX2Cleared 510(K)
- K091364DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.42Cleared 510(K)
- K092125PRESIDIO PACS2Cleared 510(K)
- K093247MEDSYNAPSE PACS SOFTWARE2Cleared 510(K)
- K092639INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP2Cleared 510(K)
- K093423LUNGPOINT PROCEDURE PLANNING2Cleared 510(K)
- K092741COLOR LCD MONITOR, MODEL RADIFORCE MX241W2Cleared 510(K)
- K092954CADSTREAM VERSION 52Cleared 510(K)
- K093234INTEGRATED REGISTRATION2Cleared 510(K)
- K092581MITS DICOM GATEWAY AND IMAGE MANAGER2Cleared 510(K)
- K092949IMAGEGRID RADIOLOGY VIEWER SYSTEM2Cleared 510(K)
- K092204PMD VIEWER2Cleared 510(K)
- K092067ABVS WORKPLACE2Cleared 510(K)
- K092134STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)2Cleared 510(K)
- K092519SYNGO.X2Cleared 510(K)
- K092102NORDICBRAINEX SOFTWARE, VERSION 1.02Cleared 510(K)
- K092235BEYONDIMAGE WORKSTATION2Cleared 510(K)
- K092081QXLINK2Cleared 510(K)
- K091274CORONIS 5MP HD, MODEL MDMG 51212Cleared 510(K)
- K091687PACSMATE, MODEL MMD-4300C/MMD-4300CX2Cleared 510(K)
- K083658PACS PLUS 5TH EDITION2Cleared 510(K)
- K091262MR CARDIAC FUNCTION ANALYSIS2Cleared 510(K)
- K091001MYRIAN 1.42Cleared 510(K)
- K090668VISION TOOLS2Cleared 510(K)
- K083520INTELEPACS, MODEL VERSION 3.X.X2Cleared 510(K)
- K091032CERNER PROVISION WORKSTATION (VERSION 2.5)2Cleared 510(K)
- K090431DEXIS SOFTWARE2Cleared 510(K)
- K090546MODIFICATION TO NORDICICE SOFTWARE2Cleared 510(K)
- K091498VITREA ENDOVASCULAR STENT PLANNING SOFTWARE2Cleared 510(K)
- K091368R2 DIGITALNOW HD(DIGITALNOW HD)2Cleared 510(K)
- K090461IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.02Cleared 510(K)
- K090155CAAS MR FLOW 1.02Cleared 510(K)
- K091373SYNGO TRUED2Cleared 510(K)
- K083327SYNGOCIRCULATION DYNAMICPET, VERSION 1.02Cleared 510(K)
- K091286SYNGO US WORKPLACE2Cleared 510(K)
- K090833SEGMENT2Cleared 510(K)
- K091172NIO 2MP (MDNG-2121)2Cleared 510(K)
- K091160LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM2Cleared 510(K)
- K090607BLUE SKY BIO PLAN, VERSION .382Cleared 510(K)
- K090603BARCO 5MP MAMMO, MODEL MDMG-52212Cleared 510(K)
- K090732NIO COLOR 3MP AND MDNC-31212Cleared 510(K)
- K090215MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL2Cleared 510(K)
- K090218MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ2Cleared 510(K)
- K083910VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER2Cleared 510(K)
- K090223ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D700242Cleared 510(K)
- K083446CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING2Cleared 510(K)
- K090649VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE2Cleared 510(K)
- K081168BRIT PACS SYSTEMS2Cleared 510(K)
- K090481DEMASQ IMAGING SPFTWARE DEVICE2Cleared 510(K)
- K090552UROCARE2Cleared 510(K)
- K090095LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM2Cleared 510(K)
- K090295BODYVIZ, MODEL 1002Cleared 510(K)
- K083182DATACOM DC PACS2Cleared 510(K)
- K083691BONEVUE2Cleared 510(K)
- K082623VISIX IMAGING2Cleared 510(K)
- K082693RESOLUTIONMD, RELEASE 2.12Cleared 510(K)
- K083491NEUROSCAPE2Cleared 510(K)
- K083740MAMMODIAGNOST VU2Cleared 510(K)
- K090119SICAT IMPLANT2Cleared 510(K)
- K081556CADSTREAM, VERSION 5.02Cleared 510(K)
- K090045COLOR LCD MONITOR, RADIFORCE RX3202Cleared 510(K)
- K083618PACS SCAN2Cleared 510(K)
- K083916LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD2Cleared 510(K)
- K083149ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE2Cleared 510(K)
- K083907MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG2Cleared 510(K)
- K083332MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK2Cleared 510(K)
- K082808IMAGESVR PACS2Cleared 510(K)
- K082526CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)2Cleared 510(K)
- K083673CARESTREAM PACS, MODEL CARESTREAM PACS VII2Cleared 510(K)
- K083348IMAGE-ARENA APPLICATIONS2Cleared 510(K)
- K083084CT BRAIN PERFUSION FOR ZIOSTATION2Cleared 510(K)
- K083555PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION2Cleared 510(K)
- K082269VISAGE PACS, VERSION 6.0/CS 3.12Cleared 510(K)
- K082607MRI-PLAQUE VIEW, VERSION 1.1.20032Cleared 510(K)
- K082441NORDICICE SOFTWARE2Cleared 510(K)
- K082990INFINITT XELIS2Cleared 510(K)
- K082628CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.232Cleared 510(K)
- K082240SNTRYPACS2Cleared 510(K)
- K083018CENTRICITY PACS WEB DIAGNOSTIC2Cleared 510(K)
- K082430SYNGO IMAGING XS2Cleared 510(K)
- K082706INFINITT CARDIOLOGY PACS2Cleared 510(K)
- K082493MEDICAL DISPLAY, MD205MG-12Cleared 510(K)
- K082135SHOWCASE2Cleared 510(K)
- K082336XR-EXPRESS2Cleared 510(K)
- K0826844D VIEWER RADIOLOGY, MODEL USWP-100A2Cleared 510(K)
- K082663COLOR LCD MONITOR2Cleared 510(K)
- K082510IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.02Cleared 510(K)
- K081987UNISYN IMAGE FUSION, VERSION 1.02Cleared 510(K)
- K081985AW SERVER2Cleared 510(K)
- K082596ULTRAEXTEND USWS-900A2Cleared 510(K)
- K082228PLANISIGHT LINASYS2Cleared 510(K)
- K081948RAYPAX SYSTEM2Cleared 510(K)
- K081792SPY ANALYSIS TOOLKIT, MODEL SA90002Cleared 510(K)
- K082386INREACH PLANNING LAPTOP2Cleared 510(K)
- K082483QUANTRA2Cleared 510(K)
- K08194521.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A)2Cleared 510(K)
- K081656VISUALASE THERMAL THERAPY SYSTEM2Cleared 510(K)
- K082496PACSMATE MMD-3213M MONITOR2Cleared 510(K)
- K082144AMICAS PACS, VERSION 6.02Cleared 510(K)
- K0813575MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9)2Cleared 510(K)
- K080196Z3D CONTRAST ACUITY2Cleared 510(K)
- K082341DSA 2000EX2Cleared 510(K)
- K080529STEREOS WORKSTATION2Cleared 510(K)
- K081215VOLUMINA2Cleared 510(K)
- K082318CENTRICITY PACS IW2Cleared 510(K)
- K081672C-INSIGHT2Cleared 510(K)
- K081752EDGE PACS2Cleared 510(K)
- K082041FIATLUX VISUALIZE2Cleared 510(K)
- K081630MAMMO WORKSTATION2Cleared 510(K)
- K081976IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION2Cleared 510(K)
- K081512STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE2Cleared 510(K)
- K081402SIMPLANT ORTHO ; VISTADENT 3D2Cleared 510(K)
- K080905QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI2Cleared 510(K)
- K081843ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS12Cleared 510(K)
- K081734SYNGO IMAGING (VERSION V31)2Cleared 510(K)
- K081076VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE2Cleared 510(K)
- K081262DC NEURO2Cleared 510(K)
- K081469SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P22Cleared 510(K)
- K081304ALZ WEB PACS, VERSION 1.02Cleared 510(K)
- K08124221.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)2Cleared 510(K)
- K081308FUJIFILM FCR VIEW, MODEL CR-VW6742Cleared 510(K)
- K08105621.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A)2Cleared 510(K)
- K08105521.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A)2Cleared 510(K)
- K08095119-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A2Cleared 510(K)
- K08095215-INCH (38 CM) COLOR LCD MONITOR CDL1576A2Cleared 510(K)
- K081347ILUMA VISION2Cleared 510(K)
- K072258BI-RADS COMPANION2Cleared 510(K)
- K081109CORONIS 5MP MAMMO SL, MODEL MDMG 61212Cleared 510(K)
- K0810933-D IMAGING WORKSTATION2Cleared 510(K)
- K080890SMARTSPOT PRIMAX2Cleared 510(K)
- K081018SYNGO DYNAMICS VERSION 7.02Cleared 510(K)
- K073358LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A2Cleared 510(K)
- K080351DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI2Cleared 510(K)
- K072728SYNGO MULTIMODALITY WORKPLACE2Cleared 510(K)
- K080961NM APPLICATION SUITE2Cleared 510(K)
- K080608DIGITAL LIGHTBOX2Cleared 510(K)
- K073449SURGICASE2Cleared 510(K)
- K080770IMAGENMD WITH IMAGENQ2Cleared 510(K)
- K080325IGROK2Cleared 510(K)
- K073468MIMICS2Cleared 510(K)
- K080457COLOR LCD MONITOR, MODEL RADIFORCE RX2112Cleared 510(K)
- K073714TRAUMACAD VERSION 2.02Cleared 510(K)
- K073176KANTERON DICOM STATION (KDS), MODEL 3.02Cleared 510(K)
- K073526AMICAS VISION SERIES PACS, MODEL 5.52Cleared 510(K)
- K0804225 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS5202Cleared 510(K)
- K073062OMNI-VUE SYSTEM2Cleared 510(K)
- K073418SYNGO IMAGING CCF VA10A2Cleared 510(K)
- K080333IMAGEGRID2Cleared 510(K)
- K080290XVIEWNET2Cleared 510(K)
- K080334INSTARAD2Cleared 510(K)
- K080320PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A93002Cleared 510(K)
- K073704I-DIXEL2Cleared 510(K)
- K072821VITREA 4DCT2Cleared 510(K)
- K073194CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS2Cleared 510(K)
- K073007CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL2Cleared 510(K)
- K07179415M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2123A (MS51I2)2Cleared 510(K)
- K0726533VISEON/SURGERY2Cleared 510(K)
- K072875NIO 5MP DISPLAY, MODEL E56202Cleared 510(K)
- K073292MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM2Cleared 510(K)
- K080013REGISTRATION AND FUSION2Cleared 510(K)
- K073169SCIMAGE PICOMENTERPRISE2Cleared 510(K)
- K073306XORANCONNECT2Cleared 510(K)
- K073448MEDICAL DISPLAY, MD205MG2Cleared 510(K)
- K073259XIDF-100A/B1 IMAGE PROCESSOR2Cleared 510(K)
- K073340COLOR LCD MONITOR, FLEXSCAN MX300W2Cleared 510(K)
- K073205NIO 5MP, MODEL MDNG-51212Cleared 510(K)
- K073272WORKSTATIONONE BREAST IMAGING WORKSTATION2Cleared 510(K)
- K072637DIVO2Cleared 510(K)
- K073271ORTHOGON2Cleared 510(K)
- K072986INTEGRADWEB PACS SYSTEM2Cleared 510(K)
- K072952GE ECHOPAC2Cleared 510(K)
- K072960CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET2Cleared 510(K)
- K072972MEDSTREAMING MEDICAL OFFICE SOFTWARE2Cleared 510(K)
- K072532TRUEPIX LCD MEDICAL DISPLAY MONITOR, MODELS TX-5M, TX-3M, TX-2M2Cleared 510(K)
- K072665SUNIRAY 5.22Cleared 510(K)
- K071964MIM 4.1 (SEASTAR)2Cleared 510(K)
- K072242COR ANALYZER II, MODEL V1.72Cleared 510(K)
- K071584OASIS RELEASE 1.02Cleared 510(K)
- K072205VISAGE PACS/CS, RELEASE VERSION 5.02Cleared 510(K)
- K071492FIRSTVIEW2Cleared 510(K)
- K071894XEBRA DICOM IMAGE BROWSER2Cleared 510(K)
- K07206520.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2)2Cleared 510(K)
- K0720661.3M MONOCHROME LCD MONITOR MDL1908A2Cleared 510(K)
- K071636CODIAGNOSTIX (R) 5.722Cleared 510(K)
- K063066AXIS-V MONOCHROME 5 MP DISPLAY2Cleared 510(K)
- K071972ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS2Cleared 510(K)
- K071950SYNGO TRUED2Cleared 510(K)
- K071602IMAGIC V2.02Cleared 510(K)
- K071166UNIWEB, VERSION 5.02Cleared 510(K)
- K071599EASYGUIDE2Cleared 510(K)
- K071436REGIUS UNITEA2Cleared 510(K)
- K062878EZPACS, VERSION 3.02Cleared 510(K)
- K071297IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)2Cleared 510(K)
- K071232IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS2Cleared 510(K)
- K071241LMS-LIVER2Cleared 510(K)
- K071086RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.02Cleared 510(K)
- K071362VITAL CONNECT 4.12Cleared 510(K)
- K071331VITREA VERSION 4.02Cleared 510(K)
- K0632695MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC2Cleared 510(K)
- K071114SYNGO IMAGING (VERSION V30)2Cleared 510(K)
- K071054RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK42Cleared 510(K)
- K070831VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION2Cleared 510(K)
- K070868LMS-LUNG/TRACK2Cleared 510(K)
- K071000MYRIAN2Cleared 510(K)
- K070755INTERWORKS2Cleared 510(K)
- K070726NIO COLOR 3MP AND MDNC 31202Cleared 510(K)
- K070713IMPLANT LOCATION SOFTWARE-T2Cleared 510(K)
- K063391SAPHENEIA CLARITY2Cleared 510(K)
- K070618DICOMPACS, MODEL 52Cleared 510(K)
- K070606VISIO+CD VIEWER# KPSCDVE012Cleared 510(K)
- K070954PATIENTGALLERY IMAGING SOFTWARE2Cleared 510(K)
- K070397DGSCOPE, RELEASE 1.02Cleared 510(K)
- K070683MIRAGE CEDARS OPTION2Cleared 510(K)
- K070803INVIVODENTAL2Cleared 510(K)
- K070796CHILI PACS2Cleared 510(K)
- K070792QLAB QUANTIFICATION2Cleared 510(K)
- K070394CERNER PROVISION WORKSTATION2Cleared 510(K)
- K070205ZIOSTATION2Cleared 510(K)
- K062621NIO 5MP-21 AND MDNG-5121 CB2Cleared 510(K)
- K070464ONDEMAND3D2Cleared 510(K)
- K07037021.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122A2Cleared 510(K)
- K070226CARDIOCT2Cleared 510(K)
- K070089SYNTERMED LIVE2Cleared 510(K)
- K070248VELOCITYAIS2Cleared 510(K)
- K070322SYNGO DYNAMICS, VERSION 6.02Cleared 510(K)
- K070131RADIFORCE GX220 AND GS220 MONOCHROME LCD MONITORS2Cleared 510(K)
- K070244AEGIS2Cleared 510(K)
- K070122MONOCHROME LCD MONITOR, MODEL RADIFORCE GX3202Cleared 510(K)
- K063730DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.02Cleared 510(K)
- K063846EIGEN DSA 20002Cleared 510(K)
- K070080INTELEPACS2Cleared 510(K)
- K063294TOPACS2Cleared 510(K)
- K063548COR ANALYZER 1, VERSION 1.42Cleared 510(K)
- K063439MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS2Cleared 510(K)
- K063539NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.12Cleared 510(K)
- K063826SYNGO MI APPLICATIONS 2007A2Cleared 510(K)
- K063781PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE2Cleared 510(K)
- K063470AYCAN WORKSTATION OSIRIX2Cleared 510(K)
- K062905NIO FUSION 4MP; MDNC 41302Cleared 510(K)
- K063628CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY2Cleared 510(K)
- K0635792MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC2Cleared 510(K)
- K063505VISUALASE ENVISION SOFTWARE SYSTEM2Cleared 510(K)
- K063392IMCO-STAT2Cleared 510(K)
- K063337OPAL-RAD2Cleared 510(K)
- K063253RCHIVE PACS2Cleared 510(K)
- K063221MEDWEB ADVANCED 3D WEB PACS2Cleared 510(K)
- K06320020.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204)2Cleared 510(K)
- K063153NOVAPACS2Cleared 510(K)
- K06319921.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2)2Cleared 510(K)
- K063188DEL-IMS2Cleared 510(K)
- K06319721.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2)2Cleared 510(K)
- K06319821.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2)2Cleared 510(K)
- K063344CAAS QCA 3D2Cleared 510(K)
- K063327ORTHOVIEW2Cleared 510(K)
- K062985IVUS ENHANCER2Cleared 510(K)
- K062237CADI, VERSION 42Cleared 510(K)
- K062131NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB2Cleared 510(K)
- K0632892MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC2Cleared 510(K)
- K061696IQQA-LIVER SOFTWARE2Cleared 510(K)
- K0632663MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC2Cleared 510(K)
- K063267ISITE PACS, V 4. X2Cleared 510(K)
- K063120COLOR LCD MONITOR, RADIFORCE, MODEL RX2102Cleared 510(K)
- K063093SECTRA WORKSTATION, VERSION 11.12Cleared 510(K)
- K062757XERON PACS2Cleared 510(K)
- K063031PRISM VIEW, MODEL2Cleared 510(K)
- K063006GE LOGIQ WORKS2Cleared 510(K)
- K062743UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.02Cleared 510(K)
- K062598IMT.LAB SOFTWARE2Cleared 510(K)
- K0631073DNET SUITE2Cleared 510(K)
- K062490VISAGE PACS/CS, RELEASE VERSION 4.12Cleared 510(K)
- K062477AMICAS VISION SERIES PACS, MODEL 4.32Cleared 510(K)
- K060836VISTADENT OC - VERSION 42Cleared 510(K)
- K063037CENTARISONE RIS/PACS2Cleared 510(K)
- K0620545 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS5102Cleared 510(K)
- K062031CHASE CARDIAC ANALYSIS SYSTEM2Cleared 510(K)
- K062163MIMVIEWER2Cleared 510(K)
- K062164RESOLUTIONMD, VERSION 1.32Cleared 510(K)
- K062650EP NAVIGATOR SOFTWARE2Cleared 510(K)
- K062488IQ-SYSTEM PACS SYSTEM2Cleared 510(K)
- K061972CONNECT IMAGING PACS2Cleared 510(K)
- K061532GENTLE COLON (REVISION 2.0)2Cleared 510(K)
- K062229CTC WORKSTATION, MODEL 22002Cleared 510(K)
- K062062VOYAGER PACS SYSTEM2Cleared 510(K)
- K062059AIE REGION OF INTEREST IMAGE ENHANCEMENT2Cleared 510(K)
- K061995XCELERA2Cleared 510(K)
- K061961ART LAB SOFTWARE2Cleared 510(K)
- K061927CORONIS COLOR 3MP AND MDCC 3120-DL2Cleared 510(K)
- K061924CORONIS 3MP AND MDCG 3120-CB2Cleared 510(K)
- K061928CORONIS COLOR 2MP AND MDCC 21212Cleared 510(K)
- K062328VITREAACCESS, VERSION 1.02Cleared 510(K)
- K061920NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER2Cleared 510(K)
- K062107SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-00032Cleared 510(K)
- K061926CORONIS 2MP AND MDCG 2121 - CB2Cleared 510(K)
- K062154VITAL CONNECT 4.02Cleared 510(K)
- K061855NEUROQUANT2Cleared 510(K)
- K062053MONOCHROME LCD MONITOR, RADIFORCE, GS3202Cleared 510(K)
- K061964SYNGO MULTIMODALITY WORKPLACE2Cleared 510(K)
- K06194721.3 INCH MONOCHROME LCD MONITOR2Cleared 510(K)
- K061421ERAD PACS2Cleared 510(K)
- K0614475M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)2Cleared 510(K)
- K061418QUANTIVA2Cleared 510(K)
- K061672SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS2Cleared 510(K)
- K061671SYNGO TRUED, MODEL VC10A2Cleared 510(K)
- K061624VITREA, VERSION 3.92Cleared 510(K)
- K061472GALILEOS IMPLANT, V 1.02Cleared 510(K)
- K061160M-VU CAD STATION2Cleared 510(K)
- K06106120.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204)2Cleared 510(K)
- K061035TIGERVIEW PROFESSIONAL2Cleared 510(K)
- K061396QLAB QUANTIFICATION SOFTWARE2Cleared 510(K)
- K061372CENTRICITY AW SUITE OPTION2Cleared 510(K)
- K061326VOXAR 3D ENTERPRISE WITH CARDIAMETRIX2Cleared 510(K)
- K061305MEDICAL DISPLAY, MDC1900-1LG (1LR)2Cleared 510(K)
- K061303MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR2Cleared 510(K)
- K0609503MATIC2Cleared 510(K)
- K060816MIM 4.0 (NEURO2Cleared 510(K)
- K061214AQUARIUSAPS SERVER2Cleared 510(K)
- K061126ACCUREX2Cleared 510(K)
- K061029JETSTREAM WORKSPACE2Cleared 510(K)
- K06096115-INCH (38CM) COLOR LCD MONITOR CDL1566A2Cleared 510(K)
- K061018PLANAR DOME EX LINE MODEL DOME E2C2Cleared 510(K)
- K060992SYNGO US WORKPLACE2Cleared 510(K)
- K060845MONOCHROME LCD MONITOR, RADIFORCE MODEL GS3102Cleared 510(K)
- K060941CAAS MRV VERSION 3.02Cleared 510(K)
- K060840SVIEW2Cleared 510(K)
- K052424MAXILIM2Cleared 510(K)
- K060505VOXAR 3D ENTERPRISE, MODEL 6.12Cleared 510(K)
- K060451M-VU VIEWER STATION2Cleared 510(K)
- K060267VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE2Cleared 510(K)
- K060263IQPACS2Cleared 510(K)
- K060453AZE VIRTUALPLACE2Cleared 510(K)
- K060378VITREA2 VERSION 3.8.12Cleared 510(K)
- K060035MDXNET2Cleared 510(K)
- K053039CLINTON ELECTRONICS SERIES II DIGITAL GRAYSCALE MONITORS, MODELS DL2000, DL3000, DL2000 OF AND DL3000 OF2Cleared 510(K)
- K053183JIVE X SOFTWARE2Cleared 510(K)
- K060210MEDIPORT2Cleared 510(K)
- K053592SIMPLANT DR. JAMES2Cleared 510(K)
- K060055KODAK PACS2Cleared 510(K)
- K053301CEDARA I-RESPONSE CEDARA PET/CT2Cleared 510(K)
- K060136PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR2Cleared 510(K)
- K053455ENCOMPASS.NET2Cleared 510(K)
- K053347KODAK CARESTREAM PACS2Cleared 510(K)
- K052988CAAS2Cleared 510(K)
- K05294221.3INCH MONOCHROME LCD MONITOR2Cleared 510(K)
- K053458WEB10002Cleared 510(K)
- K052467BRAIN VIEWRX VIEWER, VERSION 1.02Cleared 510(K)
- K052120LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM502Cleared 510(K)
- K052632VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE2Cleared 510(K)
- K053162DEXTROSCOPE & DEXTROBEAM2Cleared 510(K)
- K053281EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)2Cleared 510(K)
- K053133SYNGO DYNAMICS, VERSION 5.02Cleared 510(K)
- K052963MEDIQ VERSION 1.02Cleared 510(K)
- K053155VIMPLANT2Cleared 510(K)
- K053010VISTADENT AT COMPLETE, MODEL 3.12Cleared 510(K)
- K053043ENCOMPASS SOFTWARE PACKAGE2Cleared 510(K)
- K052618IMAGECAST PACS2Cleared 510(K)
- K052958COLOR NIO 2MP, E-2320 C2Cleared 510(K)
- K052537CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.02Cleared 510(K)
- K052995ADVANTAGE WORKSTATION 4.3.2Cleared 510(K)
- K052545INFINITT G3 PACS2Cleared 510(K)
- K052775SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP)2Cleared 510(K)
- K052379MIM 3.5 (CIRCA)2Cleared 510(K)
- K052895FOURSIGHT VIEWTOOL IMAGE VIEWER2Cleared 510(K)
- K052284REFORMAT GATEWAY2Cleared 510(K)
- K052312WIDE 5MP (MAMMO) LCD MONITOR SYSTEM2Cleared 510(K)
- K052358ETIAM STAR PACS COMPONENTS2Cleared 510(K)
- K052529E-2320 PA S2Cleared 510(K)
- K052352COLOR CORONIS 2MP-21 AND MFCD 23212Cleared 510(K)
- K052478MFCD 1219, MFCD 1219 TS2Cleared 510(K)
- K052461SYNGO IMAGING VERSION V20A2Cleared 510(K)
- K05219921.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)2Cleared 510(K)
- K052460POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE2Cleared 510(K)
- K052411HIPAX MEDICAL IMAGING SOFTWARE2Cleared 510(K)
- K052276NIO 2MP-20 AND E-2620 S2Cleared 510(K)
- K052429CORONIS 3MP-21 AND MFGD 36212Cleared 510(K)
- K052403CORONIS 2MP-21 AND MFGD 26212Cleared 510(K)
- K052344COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C2Cleared 510(K)
- K052337MONOCHROME LCD MONITOR, MODEL RADIFORCE G332Cleared 510(K)
- K052159AIDA COMPACT II SYSTEM2Cleared 510(K)
- K051853CARDIOSTREAM SONOAIM2Cleared 510(K)
- K051901NIO 3MP-212Cleared 510(K)
- K051840ENSITE VERISMO SOFTWARE2Cleared 510(K)
- K051809EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM2Cleared 510(K)
- K051813ULTRAPACS2Cleared 510(K)
- K051902NIO 2MP-212Cleared 510(K)
- K051586VIEWSEND MEDICAL SYSTEM2Cleared 510(K)
- K051715STARPACS DENTAL2Cleared 510(K)
- K051649VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.02Cleared 510(K)
- K051639AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM2Cleared 510(K)
- K051743R2 BREAST IMAGING WORKSTATION2Cleared 510(K)
- K0508623TP WORKSPACE2Cleared 510(K)
- K051528MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE2Cleared 510(K)
- K051523REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION2Cleared 510(K)
- K051673XELERIS 2 PROCESSING AND REVIEW WORKSTATION2Cleared 510(K)
- K051745ECHOSYSTEM2Cleared 510(K)
- K05140319-INCH (48CM) COLOR LCD MONITOR CDL1904A2Cleared 510(K)
- K051553FUJI SYNAPSE WORKSTATION SOFTWARE2Cleared 510(K)
- K051392BTI-SCAN, VERSION 4.02Cleared 510(K)
- K051521REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION2Cleared 510(K)
- K051037IMAGEQUBE PACS2Cleared 510(K)
- K05133119-INCH (48 CM) COLOR LCD MONITOR CDL1902A2Cleared 510(K)
- K051315MODIFICATION TO: SECTRA IDS5 WORKSTATION2Cleared 510(K)
- K051325WEBPAX, MODEL 2002Cleared 510(K)
- K051127KIKA IMAGING LAB VIEWER, MODEL 2.0.1.02Cleared 510(K)
- K051201E1 MEDICAL FLAT PANEL DISPLAY SYSTEM AND MFGD 1218 MEDICAL FLAT PANEL DISPLAY2Cleared 510(K)
- K050993MMS VIDEO OPTION2Cleared 510(K)
- K050846B-CAD SYSTEM, VERSION 1.02Cleared 510(K)
- K050943GE VIEWPOINT2Cleared 510(K)
- K051081ESSENPACS2Cleared 510(K)
- K050736IMORGON ULTRASOUND PACS SOLUTIONS2Cleared 510(K)
- K05061920.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & DV3MC-HB2Cleared 510(K)
- K05061721.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB2Cleared 510(K)
- K050751IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X2Cleared 510(K)
- K050744KAVO ERGOCOM/ERGOCAM2Cleared 510(K)
- K050703QBRAIN2Cleared 510(K)
- K05061621.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250I & DV2MC-HB2Cleared 510(K)
- K05048520.8-INCH(53CM) MONOCHROME LCD MONITOR MDL2110A (ME351I), (DV3MM-HB)2Cleared 510(K)
- K050376PROWIN2Cleared 510(K)
- K050667R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE2Cleared 510(K)
- K050341IMPLANT LOCATION SOFTWARE, MODEL 0.1.02Cleared 510(K)
- K050298IPACS PRISM-5.02Cleared 510(K)
- K050196SECTRA IDS5 WORKSTATION2Cleared 510(K)
- K050228AGFA HEARTLAB CARDIOVASCULAR2Cleared 510(K)
- K050033LUCION2Cleared 510(K)
- K042755MONOCHROME LCD MONITOR, RADIFORCE G512Cleared 510(K)
- K043122SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY2Cleared 510(K)
- K043483RADIN, MODEL V 3.02Cleared 510(K)
- K04343020.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3MC-HB2Cleared 510(K)
- K043415CENTRICITY PACS SYSTEM2Cleared 510(K)
- K043194VOXAR 3D PRODUCT FAMILY2Cleared 510(K)
- K043216CADSTREAM VERSION 4.02Cleared 510(K)
- K042868MAMMOREPORT SOFTCOPY WORKSTATION2Cleared 510(K)
- K043360IMT.LAB2Cleared 510(K)
- K043146HORIZON MEDICAL IMAGING2Cleared 510(K)
- K042221CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM2Cleared 510(K)
- K041078SURGPLAN AND PANPLAN2Cleared 510(K)
- K043412MODIFICATION TO: VIEWSTATION2Cleared 510(K)
- K043350MISTAR, MODEL V3.22Cleared 510(K)
- K043333VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM2Cleared 510(K)
- K043134METRX WORKSTATION2Cleared 510(K)
- K042995X-LEONARDO2Cleared 510(K)
- K042353AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS2Cleared 510(K)
- K042942MGP 15 DICOM THEATER2Cleared 510(K)
- K042662NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM2Cleared 510(K)
- K0430973VISEON2Cleared 510(K)
- K042697SECOND LOOK VIEWER2Cleared 510(K)
- K042660NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM2Cleared 510(K)
- K042661NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM2Cleared 510(K)
- K042816TRAUMACAD 1.22Cleared 510(K)
- K042700IMAGE MEDICAL ACQUISITION STATION (IMAS)2Cleared 510(K)
- K042867PHILIPS ORTHOPAEDIC APPLICATIONS2Cleared 510(K)
- K042832SIENET COSMOS (VERSION V15A)2Cleared 510(K)
- K042212IMPLANTMASTER2Cleared 510(K)
- K042383RSA-CMS2Cleared 510(K)
- K042781IPACS CARDIO2Cleared 510(K)
- K042634WIDE 1MP LCD MONITOR SYSTEM2Cleared 510(K)
- K042692CLARITY FUSION2Cleared 510(K)
- K042647EXAM-PACS2Cleared 510(K)
- K042525CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION2Cleared 510(K)
- K042507UBIPACS2Cleared 510(K)
- K042334ALLURA 3D-CA, RELEASE 12Cleared 510(K)
- K042203LEONARDO SYNGO CARDIOLOGY WORKSTATION2Cleared 510(K)
- K042042ULTRASOUND CAPTURE SYSTEM2Cleared 510(K)
- K042313INTEGRADWEB MPR/MIP2Cleared 510(K)
- K042311PACSPARTNER2Cleared 510(K)
- K042292ISITE PACS2Cleared 510(K)
- K042008ULTRAVISUAL2Cleared 510(K)
- K041508BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM2Cleared 510(K)
- K041935DR SYSTEMS PACS, RELEASE 6.12Cleared 510(K)
- K041782SEEMOR 5.0 IMAGE DISPLAY PROGRAM2Cleared 510(K)
- K041555SECURVIEW DX SOFTCOPY WORKSTATION2Cleared 510(K)
- K041990FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP2Cleared 510(K)
- K041484UNDECIDED2Cleared 510(K)
- K040686M'ATH STD2Cleared 510(K)
- K041682CAAS MRV2Cleared 510(K)
- K041326MEDCOMMONS OPEN RADIOLOGY GATEWAY2Cleared 510(K)
- K041162ORTHO-CMS2Cleared 510(K)
- K040931PATXFER RT2Cleared 510(K)
- K040896MODIFICATION TO ENCOMPASS2Cleared 510(K)
- K041761RAPIDIACOLON2Cleared 510(K)
- K0417375M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)2Cleared 510(K)
- K041029KINETDX2Cleared 510(K)
- K040970LEONARDO2Cleared 510(K)
- K041597MONOCHROME LCD MONITOR, MODEL RADIFORCE G222Cleared 510(K)
- K041581COMPACS, VERSION 1.02Cleared 510(K)
- K041500STARPACS ORTHOPEDICS SYSTEM2Cleared 510(K)
- K040310NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS2Cleared 510(K)
- K040443DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I2Cleared 510(K)
- K04069721.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A)2Cleared 510(K)
- K041366IPACS ORTHO2Cleared 510(K)
- K040746MRA-CMS2Cleared 510(K)
- K04069521,3-INCH (54CM) MONOCHROME LCD MONITOR ME213L (MDL2108A)2Cleared 510(K)
- K033859BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY2Cleared 510(K)
- K041270CT COLONOGRAPHY II2Cleared 510(K)
- K040555IMPAX CLIENT EMBRACE2Cleared 510(K)
- K033849SIMPLANT SYSTEM2Cleared 510(K)
- K040982COLOR LCD MONITOR, MODEL RADIFORCE R122Cleared 510(K)
- K040344IMPAX OT3000 ORTHOPEDIC WORKSTATION2Cleared 510(K)
- K033912CRADLE PACS2Cleared 510(K)
- K040376SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE2Cleared 510(K)
- K040365COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM2Cleared 510(K)
- K040546IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS2Cleared 510(K)
- K040852PREVIEW TREATMENT PLANNING SOFTWARE2Cleared 510(K)
- K040468CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO2Cleared 510(K)
- K033153DICOM THEATER2Cleared 510(K)
- K0316615M MEDICAL FLAT PANEL DISPLAY, ME511L2Cleared 510(K)
- K033006MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE2Cleared 510(K)
- K040876ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE2Cleared 510(K)
- K040126VIATRONIX V3D COLON, REVISION 1.32Cleared 510(K)
- K033104MGD 2621P MEDICAL GREYSCALE DISPLAY2Cleared 510(K)
- K033005MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY2Cleared 510(K)
- K033103MGD 2621L MEDICAL GREYSCALE DISPLAY2Cleared 510(K)
- K033004MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY2Cleared 510(K)
- K040158MFCD 23202Cleared 510(K)
- K040195CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM2Cleared 510(K)
- K040399QONTRAST2Cleared 510(K)
- K040040NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM2Cleared 510(K)
- K040041NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM2Cleared 510(K)
- K040050INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT35002Cleared 510(K)
- K040039NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM2Cleared 510(K)
- K033955RTIST2Cleared 510(K)
- K033920CAAS II RVA2Cleared 510(K)
- K040486MEDIPACS2Cleared 510(K)
- K034059SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE2Cleared 510(K)
- K0325553M COLOR MEDICAL FLAT PANEL DISPLAY, CCL3162Cleared 510(K)
- K040305VITREA2 VERSION 3.52Cleared 510(K)
- K033466COLOR LCD DISPLAY, MODEL RADIFORCE R222Cleared 510(K)
- K040254INTEGRIS 3D-RA, RELEASE 4.22Cleared 510(K)
- K040227QLAB QUANTIFICATION SOFTWARE2Cleared 510(K)
- K040142ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE2Cleared 510(K)
- K033825ORTHOPACS2Cleared 510(K)
- K032531CHASE CARDIAC ANALYSIS SYSTEM2Cleared 510(K)
- K040028CA-15002Cleared 510(K)
- K033712MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.12Cleared 510(K)
- K033831SIENET COSMOS2Cleared 510(K)
- K033624PACS SOFTWARE SOLUTION 20032Cleared 510(K)
- K033400SENO ADVANTAGE2Cleared 510(K)
- K031132CONSULTIVA CASE INPUT STATION, MODEL CIS-12Cleared 510(K)
- K033013MDIFICATION TO MEDIPRIME2Cleared 510(K)
- K033361VIATRONIX V3D VASCULAR, REVISION 1.02Cleared 510(K)
- K033093ECHOCONNEX COMMUNICATOR2Cleared 510(K)
- K031473RATIONAL IMAGING PACS2Cleared 510(K)
- K033088SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.12Cleared 510(K)
- K032748VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE2Cleared 510(K)
- K032546HOLOGIC DR IMAGEPRO2Cleared 510(K)
- K032533INTELEPACS2Cleared 510(K)
- K032186AUTOALIGN2Cleared 510(K)
- K032924RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK32Cleared 510(K)
- K032960WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A2Cleared 510(K)
- K032324ECHOENCODER2Cleared 510(K)
- K031590SECTRA ORTHOPEDIC PACKAGE2Cleared 510(K)
- K0315673D INVIVO BY CSIST2Cleared 510(K)
- K032176RATTAN IMACS BY RATTAN INFORMATION CORPORATION2Cleared 510(K)
- K032157TELEMIS-MEDICAL SOLUTION2Cleared 510(K)
- K032760APAX PACS SYSTEM2Cleared 510(K)
- K032638DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY2Cleared 510(K)
- K03202051CM(20.1INCH) TFT MONOCHROME LCD MONITOR, MU5111BW2Cleared 510(K)
- K032026LCD MONITOR, RADIFORCE G11, G31, G512Cleared 510(K)
- K032483VIATRONIX V3D EXPLORER, REVISION 1.22Cleared 510(K)
- K032401ORTHOVIEW2Cleared 510(K)
- K031836PHILIPS FRESCO RELEASE 12Cleared 510(K)
- K031816DVNET MDV-PACS2Cleared 510(K)
- K031562RAMSOFT PACS, MODEL 3.02Cleared 510(K)
- K031778PRACTICEBUILDER 1-2-32Cleared 510(K)
- K031779CADSTREAM2Cleared 510(K)
- K032202DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I2Cleared 510(K)
- K031704FILMLESS CLINIC2Cleared 510(K)
- K032174WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A2Cleared 510(K)
- K031638CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION2Cleared 510(K)
- K032096PHILIPS VIEWFORUM 20032Cleared 510(K)
- K0319295MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION2Cleared 510(K)
- K031372PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND DIGITAL WORKSTATION2Cleared 510(K)
- K031886SONOVIEW PRO BY MEDISON CO., LTD.2Cleared 510(K)
- K031311INTEGRADWEB BY DYNAMIC IMAGING, INC.2Cleared 510(K)
- K031248CONSULTIVA REPORT STATION, MODEL RS-12Cleared 510(K)
- K030781KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB2Cleared 510(K)
- K030751IPACS PRISM2Cleared 510(K)
- K030728FYRELINK VL2Cleared 510(K)
- K03034720.1 MONOCHROME LCD MONITOR, RADIFORCE G202Cleared 510(K)
- K030274MEDICAL FLAT PANEL DISPLAY, ME315L2Cleared 510(K)
- K030272FLAT PANEL DISPLAY, ME183L2Cleared 510(K)
- K030276FLAT PANEL DISPLAYS, CDL SERIES2Cleared 510(K)
- K031013INFINTT CO., LTD. STARPACS SYSTEM2Cleared 510(K)
- K030982SYNGO COLONOGRAPHY SOFTWARE PACKAGE2Cleared 510(K)
- K030457REX, VERSION 3.02Cleared 510(K)
- K030635THE OBSIDIAN PACS SYSTEM2Cleared 510(K)
- K030363ORG@NIZER, MODEL VERSION 3.02Cleared 510(K)
- K02435820.1 MONOCHROME LCD MONITOR, RADIFORCE G212Cleared 510(K)
- K030242FYRELINK2Cleared 510(K)
- K024159STRYKERWARE SYSTEM2Cleared 510(K)
- K030223SONOCALC2Cleared 510(K)
- K022877OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM2Cleared 510(K)
- K024103IVUS PLUS2Cleared 510(K)
- K024028SHARP VIEW IMAGE ENHANCEMENT SYSTEM2Cleared 510(K)
- K023533BARCO MEDIS 5MP2 AURA2Cleared 510(K)
- K024137JUPITER PROCESSING AND REVIEW WORKSTATION2Cleared 510(K)
- K023460PACSPLUS2Cleared 510(K)
- K023476UNIPACS WORKSTATION2Cleared 510(K)
- K023467HCP DICOM NET2Cleared 510(K)
- K023394UNISIGHT SYSTEM WITH UNIGATE2Cleared 510(K)
- K023877Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN2Cleared 510(K)
- K023339IMAGETILE2Cleared 510(K)
- K023341CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM2Cleared 510(K)
- K023340CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM2Cleared 510(K)
- K023322CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM2Cleared 510(K)
- K023246AMALGA PACS2Cleared 510(K)
- K023936MODIFICATION TO MEDIPRIME2Cleared 510(K)
- K023137PHILIPS EASYVISION WORKSTATION RELEASE 62Cleared 510(K)
- K022773BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM2Cleared 510(K)
- K023772KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM2Cleared 510(K)
- K022970AMICAS LIGHT BEAM WORKSTATION, MODEL 1.02Cleared 510(K)
- K023003IMAGECHECKER-CT WORKSTATION2Cleared 510(K)
- K023557CENTRICITY PACS PLUS2Cleared 510(K)
- K023440PHILIPS DIGITAL IMAGING OPTION RELEASE 12Cleared 510(K)
- K022938VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK32Cleared 510(K)
- K022788PHILIPS HARMONY RELEASE 12Cleared 510(K)
- K023190E.CAM COMPUTER / E.SOFT WORKSTATION2Cleared 510(K)
- K022881CEDARA I-SOFTVIEW2Cleared 510(K)
- K022824ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X2Cleared 510(K)
- K023100ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS2Cleared 510(K)
- K022940IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.02Cleared 510(K)
- K022710SMARTPACS2Cleared 510(K)
- K022692VOXELPLUS PACS2Cleared 510(K)
- K022585KIMAX QMA2Cleared 510(K)
- K022896CSV12 SOFTWARE VIEWER2Cleared 510(K)
- K022292IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO2Cleared 510(K)
- K022789VIATRONIX V3D EXPLORER2Cleared 510(K)
- K021913CALSCOR SOFTWARE2Cleared 510(K)
- K021738FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES2Cleared 510(K)
- K021934MODIFICATION TO MEDSTATION2Cleared 510(K)
- K021583PATXFER2Cleared 510(K)
- K022428QUANTITATIVE BLOOD POOL SPECT (QBS)2Cleared 510(K)
- K022310ADVANTAGE WINDOWS X-RAY/MR FUSION2Cleared 510(K)
- K021236SURGERY AND ACCESSORIES2Cleared 510(K)
- K022109EIZO, MODEL FC-20912Cleared 510(K)
- K021191AUTOALIGN2Cleared 510(K)
- K020073MEDICAL ADMINISTRATOR2Cleared 510(K)
- K021966Q LAB SOFTWARE2Cleared 510(K)
- K021314SCEPTRE-VS2Cleared 510(K)
- K021099REX, VERSION 1.02Cleared 510(K)
- K021072FILMSAVER, NT VERSION 5.032Cleared 510(K)
- K021669PHYSICIAN'S DESKTOP REVIEW2Cleared 510(K)
- K020449CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM2Cleared 510(K)
- K020546FUSION 7D2Cleared 510(K)
- K020995EFILM WORKSTATION WITH MODULES2Cleared 510(K)
- K020058MEDICAL LE2Cleared 510(K)
- K020061IMAGEDESK2Cleared 510(K)
- K020059MFCD 118I2Cleared 510(K)
- K020658VIATRONIX V3D COLON2Cleared 510(K)
- K020483ADVANTAGE WORKSTATION 4.12Cleared 510(K)
- K012439DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM2Cleared 510(K)
- K013994MODIFICATION TO VIEWSEND MEDICAL2Cleared 510(K)
- K020140VOXAR'S CALCIUM SCORING PRODUCT2Cleared 510(K)
- K013922CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM2Cleared 510(K)
- K0138413DFIS, MODEL IES-FL-1012Cleared 510(K)
- K013574ACCENT2Cleared 510(K)
- K014058ENTEGRA PE PERSONAL DIGITAL ASSISTANT2Cleared 510(K)
- K013419NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM2Cleared 510(K)
- K012327CSIST DICOM GATEWAY/IMAGE MANAGER2Cleared 510(K)
- K013878CYBERMED, INC., V-WORKS2Cleared 510(K)
- K013098KIMAX REMOTE VIEWING STATION2Cleared 510(K)
- K013630ISITE RADIOLOGY2Cleared 510(K)
- K012844MAROSIS PACS2Cleared 510(K)
- K011196IQUANTIFY, VERSION 1.02Cleared 510(K)
- K012779ICONNECTION 3D2Cleared 510(K)
- K012563DEEP GRAY2Cleared 510(K)
- K012475CAAS II QVA2Cleared 510(K)
- K012290RAPIDIA2Cleared 510(K)
- K012093AETMED IMAGE PROCESSING SOFTWARE2Cleared 510(K)
- K012086AQUARIUSNET SERVER2Cleared 510(K)
- K011694VIEWSTATION2Cleared 510(K)
- K012155KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS2Cleared 510(K)
- K012211EFILM WORKSTATION2Cleared 510(K)
- K012099MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES2Cleared 510(K)
- K011582QCU ANALYTICAL SOFTWARE PACKAGE2Cleared 510(K)
- K012097VORTEX2Cleared 510(K)
- K012072VOXAR VC, MODEL 1.02Cleared 510(K)
- K011173TELEPAX2Cleared 510(K)
- K010938SYNGO MULTIMODALITY WORKSTATION2Cleared 510(K)
- K002911XSCAN32 TELERADIOLOGY SOFTWARE2Cleared 510(K)
- K010763GOODNET2Cleared 510(K)
- K011142AQUARIUS WORKSTATION2Cleared 510(K)
- K010726MODIFICATION TO MIRAGE2Cleared 510(K)
- K010259MEDIFACE PACS2Cleared 510(K)
- K010271THINKINGNET2Cleared 510(K)
- K010571ADC QS/IPD WORKSTATION2Cleared 510(K)
- K010058IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK2Cleared 510(K)
- K002789MEDEVIEW SYSTEM2Cleared 510(K)
- K0037463D-DOCTOR2Cleared 510(K)
- K003762ALI 3D TOOL MODULE FOR MEDICAL IMAGES2Cleared 510(K)
- K010336ADVANTAGE WINDOWS CT/PET FUSION2Cleared 510(K)
- K003607ONYX-RAD TELEMEDICINE PACS2Cleared 510(K)
- K003510INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT35002Cleared 510(K)
- K003437ODYSSEY LX, MODEL 2113202Cleared 510(K)
- K003688VIEW READING STATION2Cleared 510(K)
- K003459PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW2Cleared 510(K)
- K003484NETRA WORKSTATION AND NETRAMD SOFTWARE2Cleared 510(K)
- K002942PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING2Cleared 510(K)
- K001550EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR2Cleared 510(K)
- K002894MEDIPRIME2Cleared 510(K)
- K002782HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION2Cleared 510(K)
- K001947T.I.M.S., VERSION 2.002Cleared 510(K)
- K002780VIATRONIX VISUALIZATION SYSTEM (VVS)2Cleared 510(K)
- K002724NUMALINK2Cleared 510(K)
- K002597CN ACQUISITION STATION2Cleared 510(K)
- K002590CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER2Cleared 510(K)
- K0024243D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A2Cleared 510(K)
- K002519VITREA 2, VERSION 2.12Cleared 510(K)
- K002936MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM2Cleared 510(K)
- K002144MEDLINK DIAGNOSTIC OFFLINE WORKSTATION2Cleared 510(K)
- K002039ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART2Cleared 510(K)
- K002100XIMX SYSTEM2Cleared 510(K)
- K001753MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM2Cleared 510(K)
- K001748MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM2Cleared 510(K)
- K001750MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM2Cleared 510(K)
- K001751MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM2Cleared 510(K)
- K001752MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM2Cleared 510(K)
- K001754MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM2Cleared 510(K)
- K001747MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM2Cleared 510(K)
- K001596LIFERX2Cleared 510(K)
- K001012DIGITAL INTEGRATION SYSTEM, DIS20002Cleared 510(K)
- K000770PROVIEW MEDICAL IMAGE DISPLAY MODULE2Cleared 510(K)
- K000630MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM2Cleared 510(K)
- K001140IDS5 IMAGE DISPLAY SYSTEM2Cleared 510(K)
- K000380FOTOMASTER2Cleared 510(K)
- K000395EINSTEIN PROCESSING AND REVIEW WORKSTATION2Cleared 510(K)
- K000557MEDVIZER PACS, MODEL RELEASE 20002Cleared 510(K)
- K000443REMOTE FETAL MEDICINE ULTRASOUND SYSTEM2Cleared 510(K)
- K000448PACSSTATION2Cleared 510(K)
- K000474VIEW NT2Cleared 510(K)
- K000293BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY2Cleared 510(K)
- K000292BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY2Cleared 510(K)
- K000291MFCD 1182Cleared 510(K)
- K000294MFCD 1202Cleared 510(K)
- K000014BARCOMED 5MP1H2Cleared 510(K)
- K000016BARCOMED 5MP22Cleared 510(K)
- K994270INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT30002Cleared 510(K)
- K993946PEGASYS ULTRA2Cleared 510(K)
- K994228REMOTEIMAGE SYSTEM2Cleared 510(K)
- K994054ISSA PHAROS2Cleared 510(K)
- K000015BARCOMED 2MP22Cleared 510(K)
- K994210INTURIS SUITE2Cleared 510(K)
- K993750PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO2Cleared 510(K)
- K993802SHARPVIEW IMAGE ENHANCEMENT SYSTEM2Cleared 510(K)
- K993338INTEGRATED DIGITAL MEDICAL RECORD (IDMR)2Cleared 510(K)
- K993283OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C2Cleared 510(K)
- K993761CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW2Cleared 510(K)
- K993227PHILIPS INTURIS DICOM RECORDER2Cleared 510(K)
- K993532DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES)2Cleared 510(K)
- K993530SYSTEM 21002Cleared 510(K)
- K992925AX WORKSTATION DR-VIEWER SOFTWARE OPTION2Cleared 510(K)
- K992886POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A2Cleared 510(K)
- K992654PLUG 'N VIEW 3D, VERSION 1.02Cleared 510(K)
- K992666VIDEO PLUS SYSTEM, SERIES 950002Cleared 510(K)
- K992354SNT IMAGE ANALYSIS SYSTEM2Cleared 510(K)
- K992575CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 30002Cleared 510(K)
- K990241ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP2Cleared 510(K)
- K992306SAMSUNG RAYPAX DISPLAY WORKSTATION2Cleared 510(K)
- K992112SAMSUNG RAYPAX FILM DIGITIZER2Cleared 510(K)
- K992073AX WORKSTATION2Cleared 510(K)
- K992259ECHOCARDIOGRAPHY SYSTEM SERIES 950002Cleared 510(K)
- K991738DIGITAL VIDEO RECORDING SYSTEM2Cleared 510(K)
- K991629GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C2Cleared 510(K)
- K991468IMMERGE IMAGE CORRELATION2Cleared 510(K)
- K991626WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION2Cleared 510(K)
- K991257FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION2Cleared 510(K)
- K991643IDS4 V3.2 IMAGE DISPLAY SYSTEM2Cleared 510(K)
- K991578SMARTSPOT 20002Cleared 510(K)
- K990455PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION2Cleared 510(K)
- K990442ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.32Cleared 510(K)
- K990919STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG2Cleared 510(K)
- K990759VIEW COM2Cleared 510(K)
- K990052TEL-ECHO SYSTEM2Cleared 510(K)
- K984215WELCH ALLYN FRONT-LINE DOC2Cleared 510(K)
- K983815PACSCACHE2Cleared 510(K)
- K983529INSTATRAK 30002Cleared 510(K)
- K982535INSIGHT DIAGNOSTIC IMAGING WORKSTATION2Cleared 510(K)
- K983401FRAMEWAVE WEB2Cleared 510(K)
- K983392DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR2Cleared 510(K)
- K983256ADVANTAGE WINDOWS (AW) FUSION2Cleared 510(K)
- K983821PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE2Cleared 510(K)
- K984023MAXVIEW DIAGNOSTIC WORKSTATION2Cleared 510(K)
- K982976ULTRASOUND WORKSTATION, UIWS-300A2Cleared 510(K)
- K983111XRAY VISION2Cleared 510(K)
- K982994SKULL BASE INSTATRAK SYSTEM2Cleared 510(K)
- K982769MITRA IMAGING INC. EXHIBIT2Cleared 510(K)
- K982862RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE2Cleared 510(K)
- K982820BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM2Cleared 510(K)
- K982690BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWARE2Cleared 510(K)
- K982563ULTRAPRO MODEL 982Cleared 510(K)
- K982422EAGLESOFT CHAIRSIDE2Cleared 510(K)
- K983088INSTACINE D-20002Cleared 510(K)
- K982146PICTOOLS MEDICAL TOOL KIT MODEL 1.02Cleared 510(K)
- K982120DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)2Cleared 510(K)
- K981998PEDIATRIC INSTATRAK SYSTEM2Cleared 510(K)
- K980648PRO VISION2Cleared 510(K)
- K981217PLATINUM READING, REVIEW & ANALYSIS WORKSTATION2Cleared 510(K)
- K980234THE NETWORK SYSTEM2Cleared 510(K)
- K980970IIRAD DIRECTRAY OPERATOR CONSOLE2Cleared 510(K)
- K980168COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE2Cleared 510(K)
- K980118KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER2Cleared 510(K)
- K974755DYNA VUE 3-D IMAGING PRODUCT2Cleared 510(K)
- K974504EPS2Cleared 510(K)
- K980060ECHOLINK2Cleared 510(K)
- K974474PEGASYS INTOUCH2Cleared 510(K)
- K971965PHILIPS EASYVISION2Cleared 510(K)
- K974134X-SIGHT DIGITAL IMAGING SYSTEM2Cleared 510(K)
- K974207PHILIPS EASYVISION WORKSTATION2Cleared 510(K)
- K974086KODAK DIGITAL SCIENCE CARDIAC VIEWER2Cleared 510(K)
- K973983PHILLIPS EASY VISION FAMILY WORKSTATION OPTION ENDO 3D2Cleared 510(K)
- K973835PHILIPS EASYVISION WORKSTATION2Cleared 510(K)
- K973653SEEMOR - DISPLAY & PROCESSING PROGRAM EXECUTING ON PERSONAL COMPUTER SYSTEM2Cleared 510(K)
- K973148MACOM2Cleared 510(K)
- K972215MEDIMAGE2Cleared 510(K)
- K973065REALVIEW TELEMEDICINE SYSTEM2Cleared 510(K)
- K973010REALTIME 3D DIAGNOSTIC WORKSTATION2Cleared 510(K)
- K973081DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)2Cleared 510(K)
- K972933VOX/BASE FOR WINDOWS2Cleared 510(K)
- K972886MIRAGE2Cleared 510(K)
- K972520OPTIVIEW2Cleared 510(K)
- K972256FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 (FOR NETWORKS)2Cleared 510(K)
- K972103PHILIPS EASYVISION2Cleared 510(K)
- K971973KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER2Cleared 510(K)
- K971776ECHOVACS2Cleared 510(K)
- K965179INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO2Cleared 510(K)
- K971368IDS4 IMAGE DISPLAY SYSTEM SERIES2Cleared 510(K)
- K971714NDC DENTAL SYSTEM, VERSION 1.5 X-RAY AND VIDEO2Cleared 510(K)
- K971290STRATASYS FDM MEDMODELER SYSTEM2Cleared 510(K)
- K970964MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM2Cleared 510(K)
- K970813DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/51112Cleared 510(K)
- K970623IMMERGE IMAGE CORRELATION2Cleared 510(K)
- K970617CT-MODELLER SYSTEM2Cleared 510(K)
- K970451DOWNSCAN 1202Cleared 510(K)
- K970534PICTURE ARCHIVING & COMMUNICATIONS DEVICE2Cleared 510(K)
- K970450UPSCAN 1202Cleared 510(K)
- K970349FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS6672Cleared 510(K)
- K970402DOCTORS REVIEW SYSTEM2Cleared 510(K)
- K962010EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS2Cleared 510(K)
- K964327IPU RX-22Cleared 510(K)
- K962153DIGITAL IMAGE ANALYSIS SYSTEM2Cleared 510(K)
- K963980PHILIPS EASYVISION2Cleared 510(K)
- K964124PHILIPS COMPUTED RADIOGRAPHY2Cleared 510(K)
- K963859QLVA PLUS2Cleared 510(K)
- K963697ADVANCED DIAGNOSTIC VIEWER (ADV)2Cleared 510(K)
- K963610AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES2Cleared 510(K)
- K961739KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT2Cleared 510(K)
- K961740KODAK DIGITAL SCIENCE MEDICAL PRINTER INTERFACE UNIT2Cleared 510(K)
- K963037PATRIOT2Cleared 510(K)
- K962589AURORA DIAGNOSTIC WORKSTATION2Cleared 510(K)
- K962260REAL-TIME VIDEO CONTRAST ENHANCER2Cleared 510(K)
- K961983TRS 2000 TELERADIOLOGY SYSTEM2Cleared 510(K)
- K961871FLOUROSPOT T.O.P.2Cleared 510(K)
- K961637PICKER MR WORKSTATIONS (VISTAR,MONTAGE AND ONCALL)2Cleared 510(K)
- K961403LIFE IMAGING SYSTEMS LIS 6000 A2Cleared 510(K)
- K960265ADVANTAGE WINDOWS WITH FUNCTOOL OPTION2Cleared 510(K)
- K961307SMART SPOT2Cleared 510(K)
- K953911PHILIPS EASYVISION2Cleared 510(K)
- K955457DIGISCAN 2 PLUS2Cleared 510(K)
- K955092ACCURAD IMAGE MANAGEMENT SYSTEM, AUTORAD, REGUSTRATION STATION, ARCHIVE SERVER, PRINT SPOOLER, ANALOG & DIGITAL ACQUIRE2Cleared 510(K)
- K960946ECHONET2Cleared 510(K)
- K960665ECHO-COM FOR MS-WINDOWS VERSION 2.02Cleared 510(K)
- K960613GE ADVANTAGE WINDOWS REVIEW WORKSTATION2Cleared 510(K)
- K960071IMAGEFUSION2Cleared 510(K)
- K960330INSTATRAK2Cleared 510(K)
- K960043KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM2Cleared 510(K)
- K954159DIGITAL IMAGING SYSTEM2Cleared 510(K)
- K953616PREVIEW SURGERY PLANNING SOFTWARE2Cleared 510(K)
- K954678PRO VISION2Cleared 510(K)
- K954589CLARK TUT IMAGE PROCESSING SYSTEM2Cleared 510(K)
- K955185GE ADVANTAGE DICOM CR REPROCESSING STATION2Cleared 510(K)
- K954860ECHONET2Cleared 510(K)
- K944612ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM2Cleared 510(K)
- K954222VIDEO ENHANCEMENT UNIT2Cleared 510(K)
- K954211CRISPICS2Cleared 510(K)
- K953259VOXELVIEW2Cleared 510(K)
- K954668HP ECHO IMAGE MANAGEMENT SYSTEM2Cleared 510(K)
- K953095PHILIPS EASYVISION2Cleared 510(K)
- K951262OPERATING ARM SYSTEM (OAS)2Cleared 510(K)
- K954055HDX DIGITAL IMAGING SYSTEM2Cleared 510(K)
- K952862FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR2Cleared 510(K)
- K952778CHESHIRE2Cleared 510(K)
- K952313VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION2Cleared 510(K)
- K953164ALALYSIS PACKAGE FOR DENTAL APPLICATIONS FOR XPEED, XPRESS, XVISION2Cleared 510(K)
- K945807HOMEVUE WOUND MONITORING SYSTEM2Cleared 510(K)
- K945188CEMAX VIPSTATION AND/OR SOFTWARE2Cleared 510(K)
- K941566COMPUSPEAK2Cleared 510(K)
- K945582WITT BIOMEDICAL IMAGE III2Cleared 510(K)
- K942504INSTASPOT2Cleared 510(K)
- K945428SCRIBE(TM) DIAGNOSTIC IMAGING WORKSTATION2Cleared 510(K)
- K946117MEDICAL IMAGE MANAGEMENT SYSTEM (MIM)2Cleared 510(K)
- K945389IVR MASTER2Cleared 510(K)
- K925963IMAGE TRANSPORT SERIES II2Cleared 510(K)
- K945388DFS-7002Cleared 510(K)
- K934572UNITONE2Cleared 510(K)
- K940664PAPER FILM2Cleared 510(K)
- K941093SMARTPACS FILMLESS READING AND IMAGE DISTRIBUTION SYSTEM AND CONSULTATION STATION2Cleared 510(K)
- K936179WINRAD TELERADIOLOGY SYSTEM2Cleared 510(K)
- K941933ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW)2Cleared 510(K)
- K911783ALLEGRO VIEWING WAND2Cleared 510(K)
- K932564RADSTAT2Cleared 510(K)
- K935694SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE2Cleared 510(K)
- K932371CEMAX CLINICALVIEW(TM) STATION AND/OR SOFTWARE2Cleared 510(K)
- K932372CEMAX VIPSTATION(TM) AND/OR SOFTWARE2Cleared 510(K)
- K933209VISIONTOOL2Cleared 510(K)
- K931376GAMMACON IMAGE TRANSLATION SYSTEM2Cleared 510(K)
- K925664SERIES V-SCAN RADIOGRAPHIC FILM SCANNER2Cleared 510(K)
- K930527DENTAL LINK2Cleared 510(K)
- K920851MACVIEW2Cleared 510(K)
- K924630SURGICAD(TM) VIEW(TM)2Cleared 510(K)
- K924366PERSONAL DISPLAY SYSTEM2Cleared 510(K)
- K925793TELESHARE 9102Cleared 510(K)
- K922267PHOTOPHONE(R) MULTI VIEW(TM)2Cleared 510(K)
- K925465TELERADIOLOGY DEVICE & COMPONENT OF PACS COMPONENT2Cleared 510(K)
- K924310PRESTILIX 1694 D IMAGE INTENSIFIED FLUOROSCCOPIC2Cleared 510(K)
- K923042DU PONT LINX HD-25 LASR IMAGER2Cleared 510(K)
- K923913NOISE REDUCTION UNIT W/ LAST IMAGE HOLD2Cleared 510(K)
- K920319SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI2Cleared 510(K)
- K923270KODAK EKTASCAN IMAGELINK QUALITY CONTROL WORKSTATI2Cleared 510(K)
- K921484MEDVISION2Cleared 510(K)
- K922310VORTECH'S PERSONAL DISPLAY SYSTEM2Cleared 510(K)
- K915342UD 2000 VIDEO OPTION2Cleared 510(K)
- K920950PHILIPS EASYVISION2Cleared 510(K)
- K920309SIENET DIAGNOSTIC REPORTING CONSOLE2Cleared 510(K)
- K914366MEDRAD PATHFINDER HR ROADMAPPING SYSTEM2Cleared 510(K)
- K915305OPTION U1 FOR THE DPS-PLUS SYSTEM2Cleared 510(K)
- K915542QCA PLUS2Cleared 510(K)
- K915237PHILIPS PCR-ACE SYSTEM2Cleared 510(K)
- K913755STATVIEW2Cleared 510(K)
- K913264HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE2Cleared 510(K)
- K913754CARDIO 5002Cleared 510(K)
- K912829CARDIOTRACE CARDIAC EVALUATION SYSTEMS2Cleared 510(K)
- K911752ICON TELERADIOLOGY SYSTEM2Cleared 510(K)
- K904519AGFA DIAGNOSTIC CENTER (ADC)2Cleared 510(K)
- K910437FUJI COMPUTED RADIOGRAPHY SYSTEM FCR 75012Cleared 510(K)
- K905132SHIMADZU IMAGE PROCESSOR DFS-5002Cleared 510(K)
- K905801CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO2Cleared 510(K)
- K905222CEDARS-SINAI QUANTITATIVE TI-201 ANALYSIS CTQ 2.02Cleared 510(K)
- K902428INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS2Cleared 510(K)
- K904590KODAK EKTASCAN LASER PRINTER, MODEL 100 XLP2Cleared 510(K)
- K901422SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF2Cleared 510(K)
- K902648PINNACLE IMAGE PROCESSING SYSTEM2Cleared 510(K)
- K903196IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM2Cleared 510(K)
- K901679RESUBMITTED ISG 3DMV WORKSTATION2Cleared 510(K)
- K900851DIGITAL IMAGE ENHANCEMENT SYSTEM2Cleared 510(K)
- K900697CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS2Cleared 510(K)
- K901158LITEBOX DIAGNOSTIC REVIEW WORKSTATION2Cleared 510(K)
- K897000IMAGEMASTER-101(TM)2Cleared 510(K)
- K900586MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE2Cleared 510(K)
- K896050FUJI COMPUTED RADIOGRAPHY SYSTEM FCR AC-1 (FCR)2Cleared 510(K)
- K892711QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM2Cleared 510(K)
- K894402HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL2Cleared 510(K)
- K895320FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE2Cleared 510(K)
- K892397MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS2Cleared 510(K)
- K891689MIPRON/UMIPRON2Cleared 510(K)
- K891695VIEW 10002Cleared 510(K)
- K891692MIP MR2Cleared 510(K)
- K892712MIP/CT IMAGE PROCESSING WORKSTATION2Cleared 510(K)
- K89358514 COLOR VIDEO DISPLAY 211-260-0102Cleared 510(K)
- K893521IMLOGIX 1000 IMAGE DISPLAY SYSTEM2Cleared 510(K)
- K892869ANGIOTEC ZX DIGITAL IMAGE PROCESSOR2Cleared 510(K)
- K884621DIGISCAN2Cleared 510(K)
- K890397REDI-VU MODEL RV-3862Cleared 510(K)
- K884995SIEMENS PACS/1-B (OPTICAL DISK OPTION)2Cleared 510(K)
- K885318DIGITRON 3, LV ANALYSIS PROTCOL2Cleared 510(K)
- K882933DACA-1002Cleared 510(K)
- K883476VOXEL FLINGER(TM) 3-D IMAGING SYSTEM2Cleared 510(K)
- K883604MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS)2Cleared 510(K)
- K882271CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALY2Cleared 510(K)
- K881481DIGITRON STENOSIS PROTOCOL2Cleared 510(K)
- K881993PXI (PERSONAL X-RAY IMAGER) 5122Cleared 510(K)
- K882205VIEWPOINT2Cleared 510(K)
- K881017DPS-33,000 WITH CENTOR OPTION2Cleared 510(K)
- K880169CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION2Cleared 510(K)
- K874865DAMON D.E.T.E.C.T IMAGE ENHANCER2Cleared 510(K)
- K873646DIGIVIEWER2Cleared 510(K)
- K872455DPS-4100 PLUS DIGITAL RADIOGRAPHY SYSTEM2Cleared 510(K)
- K870821POLYTRON MODELS 1001, 1002 AND 10042Cleared 510(K)
- K864854VIEW(TM) IMAGE PROCESSING AND VIEWING STATION2Cleared 510(K)
- K864519PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)2Cleared 510(K)
- K864927KODAK EKTASCAN IMAGE TRANS SYS T1/R1 SOFTWARE,1.102Cleared 510(K)
- K864739KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM P12Cleared 510(K)
- K863132DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE2Cleared 510(K)
- K862294THE IMAGE/R2Cleared 510(K)
- K861514VNA OPTICAL CORRELATOR2Cleared 510(K)
- K862309PC-DISPLAY2Cleared 510(K)
- K861852CSI/MPR OR CSI/MPR PLUS2Cleared 510(K)
- K861429DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE2Cleared 510(K)
- K861279FLUORO PLUS2Cleared 510(K)
- K854810FC-1000 FLUOROSCOPIC IMAGING COMPUTER2Cleared 510(K)
- K855002KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM2Cleared 510(K)
- K852284DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA2Cleared 510(K)
- K850080DIGITAL IMAGE PROCESSOR FP-2C2Cleared 510(K)
- K843708ADAC DPS-4070 DIGITAL RADIOGRAPHY SYS2Cleared 510(K)
- K844298ADAC MODEL DPS-3300M DIGITAL PROCESSING SYSTEM2Cleared 510(K)
- K844037DIGITAL FLUOROGRAPHIC IMAGING SYSTEM DIGIFORMER2Cleared 510(K)
- K844317DMI CONSOLE2Cleared 510(K)
- K844783DPS-3300 MICRO NUCLEAR MEDICINE IMAGING COMPUTER2Cleared 510(K)
- K844784DPS-33000 NUCLEAR MEDICINE IMAGING COMPUTER2Cleared 510(K)
- K832895VISION TWO, ONE/10 ONE/20 &242Cleared 510(K)
- LMADigitizer, Image, Radiological2Product Code
- LMBDevice, Digital Image Storage, Radiological1Product Code
- LMCCamera, Multi Format, Radiological2Product Code
- LMDSystem, Digital Image Communications, Radiological1Product Code
- LNHSystem, Nuclear Magnetic Resonance Imaging2Product Code
- LNISystem, Nuclear Magnetic Resonance Spectroscopic2Product Code
- LQAMedia, Reusable Image1Product Code
- MOSCoil, Magnetic Resonance, Specialty2Product Code
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2Product Code
- MUABone Sonometer2Product Code
- MUEFull Field Digital, System, X-Ray, Mammographic2Product Code
- MUIMedia, Coupling, Ultrasound2Product Code
- MWPCabinet, X-Ray System2Product Code
- MYNAnalyzer, Medical Image2Product Code
- NCSSystem, Imaging, Holography, Acoustic2Product Code
- NWEColon Computed Tomography System, Computer Aided Detection2Product Code
- OASX-Ray, Tomography, Computed, Dental2Product Code
- OEBLung Computed Tomography System, Computer-Aided Detection2Product Code
- OIIArthrogram Tray2Product Code
- OIJBiopsy Needle Guide Kit2Product Code
- OIKRadiology Dental Tray2Product Code
- OILDiscography Kit2Product Code
- OIMMri Disposable Kit2Product Code
- OIORadiographic Contrast Tray2Product Code
- OIPRadiology-Diagnostic Kit2Product Code
- OMJChest X-Ray Computer Aided Detection2Product Code
- OQQDiagnostic Ultrasonic Transducer, Robotic2Product Code
- OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance2Product Code
- OWBInterventional Fluoroscopic X-Ray System2Product Code
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile2Product Code
- PGYDisplay, Diagnostic Radiology2Product Code
- POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2Product Code
- QASRadiological Computer-Assisted Triage And Notification Software2Product Code
- QFMRadiological Computer-Assisted Prioritization Software For Lesions2Product Code
- QHAX-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device2Product Code
- QHXFluoroscopic X-Ray Image Intensifier1Product Code
- QHYSolid State Fluoroscopic X-Ray Imager2Product Code
- QIHAutomated Radiological Image Processing Software2Product Code
- QKBRadiological Image Processing Software For Radiation Therapy2Product Code
- RCCC-Arm Fluoroscopic X-Ray System2Product Code
- QTZRadiological Image Processing Software For Ablation Therapy Planning And Evaluation2Product Code
- QXLCabinet, Emission Computed Tomography System2Product Code
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Limbus Contour
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K230575
- 510(k) Type
- Special
- Applicant
- Limbus AI Inc.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/7/2023
- Days to Decision
- 37 days
- Submission Type
- Summary