510(k) Report

Devices descending from K954355

758 later devices reach Advantage Windows 3D with Navigator Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K153014Mobius3DMobius Medical Systems, LP201613—
+4K151212Ziostation2Qi Imaging, LLC20152—
+4K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+4K140920Syngo.CT ColonographySiemens Medical Solutions USA, Inc.20140—
+4K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+4K133643Syngo, CT Liver AnalysisSiemens Medi Cal Solutions, Inc.20141—
+4K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+4K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+4K130069Innova Epvision 2.0, Innova Epvision 2.0GE Healthcare20130—
+4K121916IntuitionTerarecon,Inc.201351
+4K121772Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1Philips Medical Systems Nederland B.V.201315—
+4K130393Mirada RTXMirada Medical, Ltd.201336—
+4K121762Cardiac VXGe Medical Systems, LLC2013211
+4K121292Dynapbv Body SoftwareSiemens Medical Solutions USA, Inc.20120—
+4K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+4K113456Ready ViewGe Healthcare (Ge Medical Systems Scs)20122—
+4K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+4K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+4K120073Infx-8000V withToshibamedical Systems Corporation2012203
+4K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+4K113543ONDEMAND3DCybermed, Inc.20119—
+4K113027Syngo Aortic Valveguide SoftwareSiemens Medical Solutions USA, Inc.2011151
+4K113052Infinix-CciToshiba America Medical Systems, In.C201171
+4K111209Integrated Innova - S5I System OptionGE Healthcare201182
+4K111052Syngo Neuro PBV-IRSiemens Medical Solutions USA, Inc.20111—
+4K083423Coloncad Api 3.1Medicsight Plc201170—
+4K110834AW Volumeshare 5 with Angioviz OptionGE Healthcare2011131
+4K110186Synapse 3D Liver AnalysisFujifilm Medical System U.S.A., Inc.20113—
+4K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc.201120—
+4K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+4K102687Mirada RTMirada Medical, Ltd.201037—
+4K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+4K091529Icad Veralook CTC Cad SoftwareIcad, Inc.20102—
+4K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+4K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+4K091001Myrian 1.4Intrasense20097—
+4K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+4K090552UrocareNeusoft Medical Systems Co., Ltd.20090—
+4K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+4K082830Infx-8000H, Infinix-IToshiba America Medical Systems, In.C200812
+4K081985AW ServerGe Medical Systems, LLC2008275
+4K082228Planisight LinasysPathfinder Therapeutics, Inc.200823—
+4K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+4K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C2008231
+4K080325IGROKIgrok, LLC20080—
+4K071310Syngo CT Oncology Software PackageSiemens AG2007195—
+4K070868LMS-Lung/TrackMedian Technologies20070—
+4K071000MyrianIntrasense20078—
+4K061671Syngo Trued, Model VC10ASiemens Medical Solutions200611—
+4K061587Fullcard AnalysisGE Healthcare20061—
+4K060453Aze VirtualplaceAze, Ltd.20061—
+4K043469Syngo Inspace 4DSiemens AG Medical Solutions2005218—
+4K042674Colon Car 1.2Medicsight2004209—
+5K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+5K252029AI-CVDHeartLung Corporation20250—
+5K251883MIM – LesionID ProMim Software, Inc.20250—
+5K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+5K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+5K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+5K232976VUZE SystemVuze Medical, Ltd.20240—
+5K233930MRCP+ version 2 (MRCP+ v2)Perspectum20240—
+5K233714BreViewGE Medical Systems SCS20240—
+5K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+5K223490FlightPlan for EmbolizationGE Medical Systems SCS20230—
+5K211180Liver SuiteGE Medical Systems SCS20220—
+5K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+5K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+5K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K202084DeepLook PRECISEDeeplook, Inc.20210—
+5K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+5K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+5K201583SmartCT R1.0Philips Medical Systems Nederland B.V.20211—
+5K202700ART-PlanTherapanacea20215—
+5K200323AutoContourRadformation, Inc.20207—
+5K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+5K201798myQA iONIba Dosimetry GmbH202011
+5K200274CariCloudCaristo Diagnostics20200—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K192277CardIQ FlowGE Medical Systems SCS20200—
+5K191610RTappSegana, LLC20191—
+5K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+5K191761Mobius3DVarian Medical Systems, Inc.20195—
+5K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+5K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+5K182966PLANET Onco DoseDosisoft20191—
+5K182855ProKnow DSProknow, LLC20192—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K173744ProFuse CADEigen20181—
+5K182546Alphenix, INFX-8000H/B, V8.0Canon Medical Systems Corporation201802
+5K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+5K181572Workflow BoxMirada Medical, Ltd.201825—
+5K171350Collision CheckRadformation, Inc.20174—
+5K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+5K170130Dynamic Coronary RoadmapPhilips Medical Systems Nederland B.V.20171—
+5K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+5K162025IntelliSpace Portal PlatformPhilips Medical Systems Nederlands B.V.20161—
+5K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—