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)
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- K170702mediCAD 4.02Cleared 510(K)
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- K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer2Cleared 510(K)
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- K171463ASPIRE Bellus II2Cleared 510(K)
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- K163533EzDent-i; E2; ProraView2Cleared 510(K)
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- K161113QXLink2Cleared 510(K)
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- K161118SIMPLANT Online Case Review and SIMPLANT Editor2Cleared 510(K)
- K161419Multi Modality Viewer2Cleared 510(K)
- K161685syngo®.via protoNeo (Version VA10A)2Cleared 510(K)
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- K161444DBSWIN and VistaEasy Imaging Software2Cleared 510(K)
- K160334Advanced Medical Imaging Software Suite (KSWVWR)2Cleared 510(K)
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- 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)
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- 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)
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- K153166Fusion Bx2Cleared 510(K)
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- K152746Ez3D Plus2Cleared 510(K)
- K152172Econsole12Cleared 510(K)
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- 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)
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- K151774CARESTREAM Vue Motion2Cleared 510(K)
- K143586FACT Medical Imaging Sysytem2Cleared 510(K)
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- K151850McKesson Cardiology2Cleared 510(K)
- K151353syngo.MR Neurology, syngo.MR Oncology2Cleared 510(K)
- K151687QuantorView2Cleared 510(K)
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- K150313Ablation Confirmation2Cleared 510(K)
- K151438Dentrix Ascend Imaging2Cleared 510(K)
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- K151192syngo.via MI Workflows2Cleared 510(K)
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- K141554ESIE APPS SUITE2Cleared 510(K)
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- K132095OLEA SPHERE2Cleared 510(K)
- K131447INTUITION - TDA, TVA, PARAMETRIC MAPPING2Cleared 510(K)
- K133367ORTHOVIS PREOPERATIVE PLAN2Cleared 510(K)
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- K13318521.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358)2Cleared 510(K)
- K13318121.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)2Cleared 510(K)
- K132742M-VU BREAST DENSITY2Cleared 510(K)
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- K132544TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA2Cleared 510(K)
- K132799CLARISO PACS2Cleared 510(K)
- K132586PAXERAPACS2Cleared 510(K)
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- K132188MAMMOGRAPHY VIEWER SMV6582Cleared 510(K)
- K132636DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM2Cleared 510(K)
- K121447ISCHEMA VIEW RAPID2Cleared 510(K)
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- K131873NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)2Cleared 510(K)
- K131685GE ECHOPAC2Cleared 510(K)
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- K131389JUSHA-C31 MEDICAL DISPLAY2Cleared 510(K)
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- 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)
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- K130743THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL2Cleared 510(K)
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- K130772MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR2Cleared 510(K)
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- K11149621.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR2Cleared 510(K)
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- K040039NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM2Cleared 510(K)
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- 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)
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- K03034720.1 MONOCHROME LCD MONITOR, RADIFORCE G202Cleared 510(K)
- K030276FLAT PANEL DISPLAYS, CDL SERIES2Cleared 510(K)
- K030272FLAT PANEL DISPLAY, ME183L2Cleared 510(K)
- K030274MEDICAL FLAT PANEL DISPLAY, ME315L2Cleared 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)
- K023467HCP DICOM NET2Cleared 510(K)
- K023476UNIPACS WORKSTATION2Cleared 510(K)
- K023394UNISIGHT SYSTEM WITH UNIGATE2Cleared 510(K)
- K023877Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN2Cleared 510(K)
- K023340CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM2Cleared 510(K)
- K023341CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM2Cleared 510(K)
- K023339IMAGETILE2Cleared 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)
- K020059MFCD 118I2Cleared 510(K)
- K020061IMAGEDESK2Cleared 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)
- K001754MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM2Cleared 510(K)
- K001752MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM2Cleared 510(K)
- K001751MEDIS 2MP2 QUAD-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)
- K000395EINSTEIN PROCESSING AND REVIEW WORKSTATION2Cleared 510(K)
- K000380FOTOMASTER2Cleared 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)
- K000294MFCD 1202Cleared 510(K)
- K000291MFCD 1182Cleared 510(K)
- K000014BARCOMED 5MP1H2Cleared 510(K)
- K000016BARCOMED 5MP22Cleared 510(K)
- K994270INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT30002Cleared 510(K)
- K993946PEGASYS ULTRA2Cleared 510(K)
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- K994054ISSA PHAROS2Cleared 510(K)
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- 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)
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- 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)
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- K960613GE ADVANTAGE WINDOWS REVIEW WORKSTATION2Cleared 510(K)
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- K960043KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM2Cleared 510(K)
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- 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)
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- K954668HP ECHO IMAGE MANAGEMENT SYSTEM2Cleared 510(K)
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- K952313VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION2Cleared 510(K)
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- K942504INSTASPOT2Cleared 510(K)
- K945428SCRIBE(TM) DIAGNOSTIC IMAGING WORKSTATION2Cleared 510(K)
- K946117MEDICAL IMAGE MANAGEMENT SYSTEM (MIM)2Cleared 510(K)
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- K925963IMAGE TRANSPORT SERIES II2Cleared 510(K)
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- 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)
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- 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)
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- K902428INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS2Cleared 510(K)
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- K901422SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF2Cleared 510(K)
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- 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)
- K891692MIP MR2Cleared 510(K)
- K891695VIEW 10002Cleared 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
DMI CONSOLE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K844317
- 510(k) Type
- Traditional
- Applicant
- DIMENSIONAL MEDICINE, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/26/1985
- Days to Decision
- 112 days