510(k) Report

Devices descending from K041521

469 later devices reach Volume Viewer Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243651VersaViewerGE Medical Systems SCS20250—
+1K163281FastStrokeGef Medical Systems Scs20172—
+1K152584Stroke VCARGE Medical Systems SCS20160—
+1K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+1K133649Hepatic VcarGE Medical Systems SCS20143—
+1K131498Iqqa-Liver Multimodality SoftwareEdda Technology, Inc.201316—
+1K121200Flightplan for LiverGE Healthcare20123—
+1K122164MR Vessellq XpressGE Medical Systems SCS20120—
+1K110573Ready ViewGe Healthcare (Ge Medical Systems Scs)2011381
+1K092639Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision…GE Medical Systems SCS200965—
+1K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+1K063324Pet VcarGE Healthcare20072041
+1K070248VelocityaisVelocity Medical Solutions, LLC200765—
+1K061696Iqqa-Liver SoftwareEdda Technology, Inc.2006217—
+1K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+1K052995Advantage Workstation 4.3.GE Healthcare20051134
+1K052345Advantage Sim MDGE Healthcare2005213
+2K241543DrAid™ for Liver SegmentationVinbrain Joint Stock Company20240—
+2K240620Cube NavigatorMedical Templates AG20240—
+2K233572AutofusePymedix20240—
+2K231690iCAS-LVHighrad, Ltd.20240—
+2K223152Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS20220—
+2K210830VUZE SystemVuze Medical, Ltd.20221—
+2K210807FlightPlan for LiverGE Medical Systems SCS20210—
+2K211247Pet VcarGE Medical Systems SCS20211—
+2K193289FastStroke, CT Perfusion 4DGE Medical Systems SCS20201—
+2K201092LSNImaging Biometrics, LLC20200—
+2K193281Hepatic VCARGE Medical Systems SCS20201—
+2K193261FlightPlan for EmbolizationGE Medical Systems SCS20201—
+2K191530StoneCheckerImaging Biometrics, LLC20191—
+2K183133MRCP+ v1.0Perspectum Diagnostics, Ltd.20191—
+2K180867AmCAD-UOAmcad Biomed Corporation20180—
+2K181892Ziostation2Ziosoft, Inc.20181—
+2K180522IGTFusionIgi Technologies20180—
+2K173636VelocityVarian Medical Systems, Inc.20188—
+2K153014Mobius3DMobius Medical Systems, LP201613—
+2K152352Stereo 3D option for Vision ApplicationsGE Medical Systems SCS20161—
+2K151212Ziostation2Qi Imaging, LLC20152—
+2K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+2K133643Syngo, CT Liver AnalysisSiemens Medi Cal Solutions, Inc.20141—
+2K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+2K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+2K130069Innova Epvision 2.0, Innova Epvision 2.0GE Healthcare20130—
+2K121916IntuitionTerarecon,Inc.201351
+2K121772Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1Philips Medical Systems Nederland B.V.201315—
+2K130393Mirada RTXMirada Medical, Ltd.201336—
+2K121762Cardiac VXGe Medical Systems, LLC2013211
+2K113456Ready ViewGe Healthcare (Ge Medical Systems Scs)20122—
+2K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+2K110834AW Volumeshare 5 with Angioviz OptionGE Healthcare2011131
+2K110186Synapse 3D Liver AnalysisFujifilm Medical System U.S.A., Inc.20113—
+2K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+2K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+2K091001Myrian 1.4Intrasense20097—
+2K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+2K090552UrocareNeusoft Medical Systems Co., Ltd.20090—
+2K081985AW ServerGe Medical Systems, LLC2008275
+2K082228Planisight LinasysPathfinder Therapeutics, Inc.200823—
+2K080325IGROKIgrok, LLC20080—
+2K071310Syngo CT Oncology Software PackageSiemens AG2007195—
+2K071000MyrianIntrasense20078—
+2K061671Syngo Trued, Model VC10ASiemens Medical Solutions200611—
+2K061587Fullcard AnalysisGE Healthcare20061—
+2K060453Aze VirtualplaceAze, Ltd.20061—
+3K251883MIM – LesionID ProMim Software, Inc.20250—
+3K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+3K232976VUZE SystemVuze Medical, Ltd.20240—
+3K233930MRCP+ version 2 (MRCP+ v2)Perspectum20240—
+3K233714BreViewGE Medical Systems SCS20240—
+3K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+3K223490FlightPlan for EmbolizationGE Medical Systems SCS20230—
+3K211180Liver SuiteGE Medical Systems SCS20220—
+3K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+3K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+3K202084DeepLook PRECISEDeeplook, Inc.20210—
+3K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+3K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+3K201583SmartCT R1.0Philips Medical Systems Nederland B.V.20211—
+3K202700ART-PlanTherapanacea20215—
+3K200323AutoContourRadformation, Inc.20207—
+3K201798myQA iONIba Dosimetry GmbH202011
+3K200274CariCloudCaristo Diagnostics20200—
+3K200315Ziostation2Ziosoft, Inc.20200—
+3K192277CardIQ FlowGE Medical Systems SCS20200—
+3K191610RTappSegana, LLC20191—
+3K191761Mobius3DVarian Medical Systems, Inc.20195—
+3K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+3K182966PLANET Onco DoseDosisoft20191—
+3K182855ProKnow DSProknow, LLC20192—
+3K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+3K181572Workflow BoxMirada Medical, Ltd.201825—
+3K171350Collision CheckRadformation, Inc.20174—
+3K170130Dynamic Coronary RoadmapPhilips Medical Systems Nederland B.V.20171—
+3K162025IntelliSpace Portal PlatformPhilips Medical Systems Nederlands B.V.20161—
+3K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+3K151988Visible Patient SuiteVisible Patient, Sas20154—
+3K151598VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V.20158—
+3K150193Customer Remote Console (CRC)Ge Medical Systems, LLC201512—
+3K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+3K142273EmboGuidePhilips Medical Systems Nederland B.V.20151—