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
+6K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+6K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+6K181804Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation201823
+6K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+6K173542Arterys Oncology DLArterys, Inc.20185—
+6K173475Merge PACSMerge Healthcare Incorporated201712
+6K172307Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V.20170—
+6K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+6K163668SuitestensaEbit Srl20170—
+6K170195QuantXQuantitative Insights, Inc.20174—
+6K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+6K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+6K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+6K163253Arterys Cardio DLArterys, Inc.20174—
+6K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+6K162513Arterys Software v2.0Arterys, Inc.20165—
+6K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+6K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+6K162112Caas MRVPie Medical Imaging BV20162—
+6K161201ClearRead CTRiverain Technologies, LLC20165—
+6K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+6K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+6K160088Cydar EVCydar, Ltd.20167—
+6K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+6K151887syngo VSimSiemens Medical Solutions USA, Inc.20158—
+6K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+6K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+6K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+6K151233MonacoImpac Medical Systems, Inc.201569
+6K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+6K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+6K142647mint LesionMint Medical GmbH201523
+6K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation201592
+6K132853NovapacsNovarad Corp.201462
+6K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+6K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation20147—
+6K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+6K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+6K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+6K133278Discovery Igs 740GE Medical Systems SCS201445
+6K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+6K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+6K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+6K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+6K123540Syngo CT Pulmo 3DSiemens Medical Systems, Inc.20139—
+6K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+6K123920Syngo.ViaSiemens AG Medical Solutions201363—
+6K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+6K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+6K121213VitreaadvancedVital Images, Inc.201281
+6K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+6K113715Lung Volume AnalysisToshibamedical Systems Corporation20120—
+6K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+6K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+6K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+6K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+6K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+6K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+6K111079Syngo.Via Web ViewerSiemens AG Medical Solutions20111—
+6K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+6K103480Thoracic VcarGe Medical Systems, LLC20114—
+6K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+6K092954Cadstream Version 5Confirma, Inc.200983
+6K083227Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc.200849—
+6K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc.2008168—
+6K063507Syngo Neuro PBV CTSiemens AG20060—
+7K261210Cleerly PlaqueCleerly, Inc.20260—
+7K260588Cleerly LABSCleerly, Inc.20260—
+7K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+7K252503Intelligent NRCanon, Inc.20260—
+7K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+7K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+7K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+7K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+7K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+7K243884TavipilotCaranx Medical20250—
+7K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+7K243666uOmniscanShanghai United Imaging Healthcare Co., Ltd.20250—
+7K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+7K243703TechLiveDeepHealth, Inc.20250—
+7K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+7K242919V5med Lung AIV5med, Inc.20250—
+7K2434463DXRGE Medical Systems SCS20250—
+7K243333rTOPRoclub GmbH20250—
+7K242329CT Collaboration LivePhilips Healthcare (Suzhou) Co., Ltd.20240—
+7K242512ROCC ConsolePhilips Medical Systems Nederland B.V.20240—
+7K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+7K241440HealthCCSngNano-X AI, Ltd.20240—
+7K233457RUSHutom, Inc.20240—
+7K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+7K231130TumorSight VizSimBioSys, Inc.20232—
+7K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+7K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+7K223261Open RibCanon Medical Informatics, Inc.20230—
+7K231185MapRTVision Rt, Ltd.20231—
+7K222998F3Acrew Imaging, Inc.20230—
+7K230112CAC SoftwareImbio, Inc.20230—
+7K230223iCAC DeviceBunkerhill, Inc.20236—
+7K230023ART-PlanTherapanacea Sas20233—