510(k) Report

Devices descending from K012313

580 later devices reach CT Colonography/NAVIGATOR2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+5K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+5K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+5K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+5K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+5K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+5K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+5K123920Syngo.ViaSiemens AG Medical Solutions201363—
+5K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+5K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+5K121213VitreaadvancedVital Images, Inc.201281
+5K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+5K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+5K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+5K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+5K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+5K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+5K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+5K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+5K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+5K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+5K092954Cadstream Version 5Confirma, Inc.200983
+6K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+6K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+6K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+6K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+6K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+6K243884TavipilotCaranx Medical20250—
+6K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+6K243666uOmniscanShanghai United Imaging Healthcare Co., Ltd.20250—
+6K243703TechLiveDeepHealth, Inc.20250—
+6K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+6K242919V5med Lung AIV5med, Inc.20250—
+6K243333rTOPRoclub GmbH20250—
+6K242329CT Collaboration LivePhilips Healthcare (Suzhou) Co., Ltd.20240—
+6K242512ROCC ConsolePhilips Medical Systems Nederland B.V.20240—
+6K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+6K233457RUSHutom, Inc.20240—
+6K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+6K231130TumorSight VizSimBioSys, Inc.20232—
+6K231185MapRTVision Rt, Ltd.20231—
+6K222998F3Acrew Imaging, Inc.20230—
+6K230023ART-PlanTherapanacea Sas20233—
+6K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+6K221612ClearRead CTRiverain Technologies, Inc.20220—
+6K220929ExcelsiorMerit Cro, Inc.20220—
+6K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+6K210670BU-CADTaihao Medical, Inc.20213—
+6K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+6K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+6K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd.20211—
+6K210831OnQ NeuroCortechs Labs, Inc.20213—
+6K210632Contour ProtegeAIMim Software, Inc.20215—
+6K203555AmCAD-UTAmcad Biomed Corporation20212—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+6K210850ADAS 3DAdas3D Medical S.L.20214—
+6K203669Mobius3DVarian Medical Systems, Inc.20213—
+6K202229AI MetricsAi Metrics, LLC20200—
+6K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+6K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+6K201665Collaboration LivePhilips Ultrasound, Inc.20202—
+6K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+6K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+6K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+6K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+6K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+6K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+6K183037Monaco RTP SystemElekta, Inc.201856
+6K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+6K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+6K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+6K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+6K182034Arterys MICAArterys, Inc.20183—
+6K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+6K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+6K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+6K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+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—
+6K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+6K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+6K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+6K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+6K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+6K160371NovaPACSNovarad Corporation20165—
+6K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+6K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+6K153289HealthmyneHealthmyne, Inc.20160—
+6K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+6K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+6K150843syngo®.via (version VB10A)Siemens AG201546—
+6K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+6K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+6K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+6K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+6K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235