510(k) Report

Devices descending from K010336

494 later devices reach Advantage Windows CT/Pet Fusion through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K202928DV. TargetDeepvoxel, Inc.20210—
+4K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+4K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+4K193252Contour ProtegeAIMim Software, Inc.20206—
+4K200274CariCloudCaristo Diagnostics20200—
+4K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+4K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+4K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+4K190868Cleerly LabsCleerly, Inc.20197—
+4K192424Mobius3DVarian Medical Systems, Inc.20194—
+4K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+4K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+4K173312ProBx SoftwareHarmonus, Inc.20180—
+4K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+4K170195QuantXQuantitative Insights, Inc.20174—
+4K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+4K160371NovaPACSNovarad Corporation20165—
+4K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+4K161419Multi Modality ViewerVital Images, Inc.20162—
+4K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+4K151283Lung Analysis SoftwareVital Images, Inc.20158—
+4K151233MonacoImpac Medical Systems, Inc.201569
+4K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+4K141302Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc.20142—
+4K133521Aze Phoenix SoftwareAze, Ltd.20140—
+4K140271Tablet Viewer Software for Image SuiteCarestream Health, Inc.20141—
+4K133993Caas WorkstationPie Medical Imaging201410—
+4K132824Carestream Vue Pacs Version 11.4 Carestream Vue Motion ApplicationCarestream Health, Inc.20146—
+4K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+4K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+4K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+4K120282CardnavPaieon, Inc.20120—
+4K121213VitreaadvancedVital Images, Inc.201281
+4K122026Prism Acquire Prism Process Prism ViewPrism Clinical Imaging, Inc.20120—
+4K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+4K113594C-THV SystemPaieon, Inc.20120—
+4K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+4K113076Caas a-ValvePie Medical Imaging BV20121—
+4K102687Mirada RTMirada Medical, Ltd.201037—
+4K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+4K101228Mirada XDMirada Medical, Ltd.201070—
+4K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+4K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions20096—
+4K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+4K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+4K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20051172
+4K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+5K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+5K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+5K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+5K251168Image SuiteCarestream Health, Inc.20250—
+5K251484CT:VQ4Dmedical Limited20250—
+5K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+5K243189TumorSight VizSimBioSys, Inc.20241—
+5K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+5K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K231185MapRTVision Rt, Ltd.20231—
+5K230023ART-PlanTherapanacea Sas20233—
+5K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+5K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.20220—
+5K220349TeraRecon NeuroTerarecon,Inc.20220—
+5K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+5K220779XDMirada Medical, Ltd.20220—
+5K210670BU-CADTaihao Medical, Inc.20213—
+5K210632Contour ProtegeAIMim Software, Inc.20215—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+5K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+5K203669Mobius3DVarian Medical Systems, Inc.20213—
+5K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+5K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+5K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K183037Monaco RTP SystemElekta, Inc.201856
+5K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+5K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+5K173542Arterys Oncology DLArterys, Inc.20185—
+5K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+5K171754NovaPACSNovarad Corporation201741
+5K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+5K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+5K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+5K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+5K163574Multi Modality ViewerVital Images, Inc.20171—
+5K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+5K161201ClearRead CTRiverain Technologies, LLC20165—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K161246Ez3D-i / E3Ewoosoft Co., Ltd.20162—