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
+7K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+7K223071Xenoview VDPPolarean, Inc.20220—
+7K221612ClearRead CTRiverain Technologies, Inc.20220—
+7K220929ExcelsiorMerit Cro, Inc.20220—
+7K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+7K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+7K220039AutoSegAi Medic, Inc.20221—
+7K221335D²RS and D²RS 9090Stephanix20220—
+7K220727inHEART MODELSInheart, Sas20221—
+7K203783ClariPulmoClaripi, Inc.20220—
+7K220450syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20221—
+7K210670BU-CADTaihao Medical, Inc.20213—
+7K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+7K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd.20211—
+7K210831OnQ NeuroCortechs Labs, Inc.20213—
+7K210632Contour ProtegeAIMim Software, Inc.20215—
+7K203555AmCAD-UTAmcad Biomed Corporation20212—
+7K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+7K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation202117
+7K210850ADAS 3DAdas3D Medical S.L.20214—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K203669Mobius3DVarian Medical Systems, Inc.20213—
+7K202229AI MetricsAi Metrics, LLC20200—
+7K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+7K201665Collaboration LivePhilips Ultrasound, Inc.20202—
+7K200990VIDAvisionVida Diagnostics, Inc.20202—
+7K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+7K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+7K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+7K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+7K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+7K191550BroncholabFluidda, Inc.20200—
+7K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+7K192455Merge PACSMerge Healthcare Incorporated201904
+7K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+7K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+7K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+7K183210Thoracic VCAR with GSI Pulmonary PerfusionGE Medical Systems SCS20190—
+7K183037Monaco RTP SystemElekta, Inc.201856
+7K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+7K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+7K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+7K182034Arterys MICAArterys, Inc.20183—
+7K173821LungQ SoftwareThirona Corporation20183—
+7K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+7K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+7K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+7K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+7K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+7K171829EndoNautTherenva Sas20173—
+7K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+7K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+7K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+7K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+7K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+7K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+7K160371NovaPACSNovarad Corporation20165—
+7K161246Ez3D-i / E3Ewoosoft Co., Ltd.20162—
+7K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+7K153289HealthmyneHealthmyne, Inc.20160—
+7K152696Infx-8000V, V6.20Toshibamedical Systems Corporation201681
+7K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+7K151919Vitrea CT Lung Density Analysis SoftwareVital Images, Inc.201510—
+7K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+7K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation20150—
+7K150843syngo®.via (version VB10A)Siemens AG201546—
+7K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+7K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+7K130998Syngo.Via Web ViewerSiemens AG Medical Solutions20140—
+7K130542Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.20139—
+7K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+7K121449DirectpathCybernet Systems Co., Ltd.20120—
+7K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+7K120648Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.201210—
+7K093810BF-NaviKgt, Inc.20101—
+8K260086CadAI-B DxBeamWorks, Inc.20260—
+8K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+8K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+8K260166Bunkerhill Contrast CACBunkerHill Health20260—
+8K252500CARA SystemCara Medical, Ltd.20260—
+8K251199Allia MoveoGE Medical Systems SCS202501
+8K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+8K250662Bunkerhill MACBunkerHill Health20250—
+8K243301MapRTVision Rt, Ltd.20250—
+8K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+8K250099Mobius3D (4.1)Varian Medical Systems20250—
+8K250416GBrain MRIGalileo Cds, Inc.20251—
+8K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+8K243229Bunkerhill AVCBunkerHill Health20253—
+8K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+8K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+8K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+8K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+8K243189TumorSight VizSimBioSys, Inc.20241—
+8K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+8K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+8K233875Brainomix 360 e-LungBrainomix Limited20241—