510(k) Report

Devices descending from K913770

1,148 later devices reach Advantage V.S. CT/MR Rad Diagnostic Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K120637Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc.20121—
+4K120748Speedup Software OptionEsaote, S.p.A.20120—
+4K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+4K113701Visia NeuroMeVis Medical Solutions AG20121—
+4K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+4K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+4K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+4K111945Impax Next GenerationAgfa Healthcare N.V.201122
+4K110834AW Volumeshare 5 with Angioviz OptionGE Healthcare2011131
+4K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+4K110802A-Channels Lumbat Spine Coils 17; 4-Channels Lumbar Spine Coils 18Esaote, S.p.A.201111—
+4K110373Temporomanibular Coil 15Esaote, S.p.A.20110—
+4K110238G-SCANEsaote, S.p.A.201115—
+4K100670S-Scan, Model 9800020010Esaote, S.p.A.20100—
+4K092469O-Scan MR SystemEsaote, S.p.A.200918—
+4K092639Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision…GE Medical Systems SCS200965—
+4K091444PerfscapeOlea Medical20090—
+4K091001Myrian 1.4Intrasense20097—
+4K081509Monteris Medical Autolitt Laser ProbeMonteris Medical,200922—
+4K090552UrocareNeusoft Medical Systems Co., Ltd.20090—
+4K083740Mammodiagnost VUPhilips Medical Systems Nederland B.V.20090—
+4K081985AW ServerGe Medical Systems, LLC2008275
+4K081656Visualase Thermal Therapy SystemBiotex, Inc.2008101
+4K080351Dexela Dex Top Mammography Workstation, Model MamwkviDexela, Ltd.20082—
+4K073272Workstationone Breast Imaging WorkstationThree Palm Software, LLC200727—
+4K062878Ezpacs, Version 3.0Advanced Imaging Solutions, LLC20072—
+4K070868LMS-Lung/TrackMedian Technologies20070—
+4K071000MyrianIntrasense20078—
+4K063324Pet VcarGE Healthcare20072041
+4K063762Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions2007263—
+4K062164Resolutionmd, Version 1.3Calgary Scientific, Inc.20062—
+4K061421Erad PacsErad, Inc.200614—
+4K061587Fullcard AnalysisGE Healthcare20061—
+4K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+4K061214Aquariusaps ServerTerarecon,Inc.2006134—
+4K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+4K060453Aze VirtualplaceAze, Ltd.20061—
+4K052537Catella Diagnostic Workstation, Version 4.0American Medical Sales, Inc.20050—
+4K050667R2 Family of Image Display Units with R2 Uniform Display SoftwareR2 Technology, Inc.20050—
+4K050228Agfa Heartlab CardiovascularHeartlab, Inc.2005922
+4K042755Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation200515—
+4K043415Centricity Pacs SystemGe Medical Systems Information Technologies200532423
+4K043216Cadstream Version 4.0Confirma, Inc.2005263—
+4K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041431
+4K041935DR Systems Pacs, Release 6.1Dr Systems, Inc.200416
+4K041555Securview DX Softcopy WorkstationHologic, Inc.200416—
+4K040896Modification to EncompassHeartlab, Inc.200411
+4K0417375M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd.200414—
+4K041380Imagechecker-CT Software Package with Filling Defect IndicatorR2 Technology, Inc.20043—
+4K040555Impax Client EmbraceAgfa Corp.200463
+4K040344Impax OT3000 Orthopedic WorkstationAgfa Corp.20042—
+4K040876Iconnection, Version 3.2.0.0 Medical Image Processing SoftwareVital Images, Inc.200430—
+4K040305VITREA2 Version 3.5Vital Images, Inc.2004164—
+4K031132Consultiva Case Input Station, Model Cis-1Eastman Kodak Company20031—
+4K033374Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions2003295—
+4K031778Practicebuilder 1-2-3Erad Imagemedical Corp.20030—
+4K031638Cardio Vascular Information Enhanced WorkstationElectromed Imaging, Inc.20030—
+4K031248Consultiva Report Station, Model RS-1Miramedica, Inc.20031—
+4K020073Medical AdministratorBarco N.V.20020—
+4K020058Medical LEBarco N.V.20020—
+5K260811Heartvue.ProtonHeartvue.ai, Inc.20260—
+5K260086CadAI-B DxBeamWorks, Inc.20260—
+5K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+5K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+5K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+5K242919V5med Lung AIV5med, Inc.20250—
+5K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+5K243189TumorSight VizSimBioSys, Inc.20241—
+5K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+5K240620Cube NavigatorMedical Templates AG20240—
+5K231662Aid-UIaid20241—
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K223152Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS20220—
+5K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+5K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+5K210830VUZE SystemVuze Medical, Ltd.20221—
+5K211039BIT-MotionDde Mri Solutions, Ltd.20210—
+5K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+5K211356GIQuantMotilent, Ltd.20210—
+5K212896Visible Patient SuiteVisible Patient, Sas20213—
+5K211247Pet VcarGE Medical Systems SCS20211—
+5K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+5K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+5K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+5K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K192277CardIQ FlowGE Medical Systems SCS20200—
+5K191125ADAS 3DGalgo Medical S.L20205—
+5K191530StoneCheckerImaging Biometrics, LLC20191—
+5K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+5K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+5K181859Visualase Thermal Therapy SystemMedtronic Navigation, Inc.201991
+5K183685O-ScanEsaote, S.p.A.20190—
+5K180867AmCAD-UOAmcad Biomed Corporation20180—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+5K182036NeuroBlate SystemMonteris Medical,201811—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K180916iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc.20180—
+5K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—