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
+5K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+5K152697Infx-8000C, V6.20Toshibamedical Systems Corporation201635
+5K152746Ez3D PlusEwoosoft Co., Ltd.20161—
+5K151988Visible Patient SuiteVisible Patient, Sas20154—
+5K151598VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V.20158—
+5K150193Customer Remote Console (CRC)Ge Medical Systems, LLC201512—
+5K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+5K142273EmboGuidePhilips Medical Systems Nederland B.V.20151—
+5K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation20152—
+5K140587MR-CT VvaMedis Medical Imaging Systems BV201519—
+5K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+5K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation20143—
+5K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+5K133535Infx-8000V, V5.30Toshibamedical Systems Corporation2014102
+5K133521Aze Phoenix SoftwareAze, Ltd.20140—
+5K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+5K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+5K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+5K132773Sidexis 4Sirona Dental Systems GmbH20131—
+5K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C20138—
+5K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+5K131616EZ3D-I, E3Ewoosoft Co., Ltd.20134—
+5K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+5K130228SuiteheartNeosoft, LLC20130—
+5K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+5K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+5K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+5K113620Myrian 1.11Intrasense20126—
+5K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+5K120484Visia OncologyMeVis Medical Solutions AG20128—
+5K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+5K113541Clearstart SVM SystemIntio, Inc.201171
+5K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+5K111642Onco Trac Model 1, 2, 4Translational Sciences Corporation20113—
+5K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+5K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+5K112054Infinix CF-I/SP and Infinix VF-I/SP Model Infx-8000VToshiba Medical Systems Corporation, Japan20110—
+5K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+5K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+5K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+5K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+5K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+5K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+5K081556Cadstream, Version 5.0Confirma, Inc.20099—
+5K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc.20080—
+5K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions2007210—
+5K071241LMS-LiverMedian Technologies20079—
+5K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc.2006169—
+5K062673Modification to Syngo Inspace 4DSiemens AG Medical Solutions2006172—
+5K061214Aquariusaps ServerTerarecon,Inc.2006134—
+5K053024Syngo Neuro Dsa CTSiemens AG20058—
+6K260597Virtue QAProNova Solutions20260—
+6K260811Heartvue.ProtonHeartvue.ai, Inc.20260—
+6K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.20260—
+6K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+6K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+6K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+6K251363ProKnow DSElekta Solutions AB20250—
+6K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+6K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+6K250755DS Core DiagnosisDentsply Sirona, Inc.20250—
+6K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+6K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+6K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+6K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+6K233660nCommand Lite SystemIonic Health20240—
+6K232744syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH20234—
+6K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+6K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+6K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+6K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+6K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+6K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+6K220813Art-PlanTherapanacea20224—
+6K212915MVision AI SegmentationMVision AI20221—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K213479D²RS and D²RS 9090Stephanix20211—
+6K212887RTappSegana, Inc.20210—
+6K212896Visible Patient SuiteVisible Patient, Sas20213—
+6K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+6K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+6K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+6K202928DV. TargetDeepvoxel, Inc.20210—
+6K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+6K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+6K193252Contour ProtegeAIMim Software, Inc.20206—
+6K200899Quantib AI NodeQuantib B.V.20200—
+6K200887AS-10Canon, Inc.20200—
+6K200179Collaboration LivePhilips Health Care20204—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+6K191125ADAS 3DGalgo Medical S.L20205—
+6K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+6K192424Mobius3DVarian Medical Systems, Inc.20194—
+6K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+6K190232Synapse PACSFujifilm Corporation2019311
+6K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+6K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+6K180916iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc.20180—
+6K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA20181—