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)
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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)
- 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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