510(k) Report

Devices descending from K020483

872 later devices reach Advantage Workstation 4.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K182310Volpara Imaging SoftwareVolpara Health Technologies Limited20182—
+6K182230Multi Modality ViewerVital Images, Inc.20180—
+6K181185Change Healthcare Enterprise ViewerChange Healthcare Canada Company201802
+6K181572Workflow BoxMirada Medical, Ltd.201825—
+6K173574DenSeeMammoStatlife20180—
+6K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+6K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+6K180019CAAS WorkstationPie Medical Imaging BV20188—
+6K172832Insight BDSiemens Medi Cal Solutions, Inc.20180—
+6K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+6K173542Arterys Oncology DLArterys, Inc.20185—
+6K173588Illumeo SystemPhilips Medical Systems Technologies, Ltd.20182—
+6K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+6K171350Collision CheckRadformation, Inc.20174—
+6K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+6K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+6K163623QuantraHologic, Inc.20170—
+6K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+6K171829EndoNautTherenva Sas20173—
+6K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+6K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+6K163232Vitrea ViewVital Images, Inc.20177—
+6K163071vascuCAPElucid Bioimaging, Inc.20173—
+6K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+6K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc.20170—
+6K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+6K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+6K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+6K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+6K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+6K161201ClearRead CTRiverain Technologies, LLC20165—
+6K1619555D ViewerSamsung Medison Co., Ltd.20163—
+6K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+6K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+6K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+6K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+6K150713syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc.20151—
+6K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+6K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+6K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+6K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+6K143361Mammo WorkstationGE Healthcare20151—
+6K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+6K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+6K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+6K141855ClarityElekta, Ltd.20140—
+6K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+6K141329RadspaTelerad Tech Private Limited20140—
+6K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+6K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+6K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+6K123920Syngo.ViaSiemens AG Medical Solutions201363—
+6K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+6K121213VitreaadvancedVital Images, Inc.201281
+6K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+6K121023Spectrum V.0Intrinsic Medical Imaging20120—
+6K120207VISIAMeVis Medical Solutions AG20120—
+6K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+6K120484Visia OncologyMeVis Medical Solutions AG20128—
+6K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+6K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+6K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+6K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+6K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+6K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+6K083691BonevueMicromri, Inc.20090—
+6K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+6K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+6K072821Vitrea 4DCTVital Images, Inc.2008171
+7K260597Virtue QAProNova Solutions20260—
+7K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+7K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+7K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+7K254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+7K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K252500CARA SystemCara Medical, Ltd.20260—
+7K252029AI-CVDHeartLung Corporation20250—
+7K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+7K251355X1-FFRSpectrawave, Inc.20250—
+7K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+7K250181AV ViewerPhilips Medical Systems Nederland B.V.20251—
+7K251766TumorSight VizSimBioSys, Inc.20250—
+7K242919V5med Lung AIV5med, Inc.20250—
+7K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+7K243614Sonio SuspectSonio20251—
+7K242130Koios DSKoios Medical, Inc.20241—
+7K242342Fetal EchoScanBrightheart20242—
+7K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+7K241245EchoSolv ASEcho IQ, Ltd.20240—
+7K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+7K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+7K241302SonoSyncSamsung Medison Co., Ltd.20240—
+7K234141AISAP Cardio V1.0Aisap20240—
+7K240281Bone Suppression SoftwareKonica Minolta, Inc.20240—
+7K232147CAAS WorkstationPie Medical Imaging BV20241—
+7K232479ART-PlanTherapanacea20232—
+7K232096Transpara Density 1.0.0Screenpoint Medical B.V.20230—
+7K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+7K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+7K230575Limbus ContourLimbus Ai, Inc.20231—