510(k) Report

Devices descending from K041521

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K243666uOmniscanShanghai United Imaging Healthcare Co., Ltd.20250—
+5K243703TechLiveDeepHealth, Inc.20250—
+5K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+5K242919V5med Lung AIV5med, Inc.20250—
+5K243333rTOPRoclub GmbH20250—
+5K242329CT Collaboration LivePhilips Healthcare (Suzhou) Co., Ltd.20240—
+5K242512ROCC ConsolePhilips Medical Systems Nederland B.V.20240—
+5K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+5K233457RUSHutom, Inc.20240—
+5K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+5K231185MapRTVision Rt, Ltd.20231—
+5K222998F3Acrew Imaging, Inc.20230—
+5K230023ART-PlanTherapanacea Sas20233—
+5K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K220929ExcelsiorMerit Cro, Inc.20220—
+5K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+5K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+5K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+5K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd.20211—
+5K210831OnQ NeuroCortechs Labs, Inc.20213—
+5K210632Contour ProtegeAIMim Software, Inc.20215—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+5K210850ADAS 3DAdas3D Medical S.L.20214—
+5K203669Mobius3DVarian Medical Systems, Inc.20213—
+5K202229AI MetricsAi Metrics, LLC20200—
+5K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+5K201665Collaboration LivePhilips Ultrasound, Inc.20202—
+5K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+5K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+5K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+5K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+5K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+5K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+5K183037Monaco RTP SystemElekta, Inc.201856
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K182034Arterys MICAArterys, Inc.20183—
+5K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+5K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+5K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+5K171829EndoNautTherenva Sas20173—
+5K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+5K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+5K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+5K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+5K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+5K153289HealthmyneHealthmyne, Inc.20160—
+5K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+5K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+5K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+5K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+5K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+5K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+6K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+6K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+6K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+6K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+6K252500CARA SystemCara Medical, Ltd.20260—
+6K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K243301MapRTVision Rt, Ltd.20250—
+6K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+6K250099Mobius3D (4.1)Varian Medical Systems20250—
+6K250416GBrain MRIGalileo Cds, Inc.20251—
+6K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+6K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+6K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+6K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+6K232479ART-PlanTherapanacea20232—
+6K223834AccuCheckManteia Technologies Co., Ltd.20231—
+6K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+6K223261Open RibCanon Medical Informatics, Inc.20230—
+6K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+6K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+6K213976Contour ProtégéAIMim Software, Inc.20224—
+6K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+6K212777Collaboration LivePhilips Ultrasound, Inc.20211—
+6K212421ADAS 3DAdas3D Medical S.L.20213—
+6K212383EndoNautTherenva Sas20212—
+6K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K192437Arterys MICAArterys, Inc.20202—
+6K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+6K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+6K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+6K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+6K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—