510(k) Report

Devices descending from K983256

477 later devices reach Advantage Windows (AW) Fusion through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+4K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+4K092954Cadstream Version 5Confirma, Inc.200983
+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—
+4K060912Modification to: HI-Art SystemTomotherapy Incorporated2006244
+4K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20051172
+4K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+5K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+5K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+5K251168Image SuiteCarestream Health, Inc.20250—
+5K251484CT:VQ4Dmedical Limited20250—
+5K242919V5med Lung AIV5med, Inc.20250—
+5K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+5K231130TumorSight VizSimBioSys, Inc.20232—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.20220—
+5K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+5K220349TeraRecon NeuroTerarecon,Inc.20220—
+5K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+5K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+5K220813Art-PlanTherapanacea20224—
+5K212915MVision AI SegmentationMVision AI20221—
+5K210670BU-CADTaihao Medical, Inc.20213—
+5K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+5K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+5K210831OnQ NeuroCortechs Labs, Inc.20213—
+5K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+5K202928DV. TargetDeepvoxel, Inc.20210—
+5K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+5K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+5K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+5K193252Contour ProtegeAIMim Software, Inc.20206—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+5K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K182034Arterys MICAArterys, Inc.20183—
+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—
+5K171754NovaPACSNovarad Corporation201741
+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—
+5K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+5K160150Vitrea CT Colon AnalysisVital Images, Inc.20160—
+5K151780CAAS WorkstationPie Medical Imaging BV20169—
+5K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+5K150713syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc.20151—
+5K151988Visible Patient SuiteVisible Patient, Sas20154—
+5K151774CARESTREAM Vue MotionCarestream Health, Inc.201541
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K143044CAAS A-ValvePie Medical Imaging BV20150—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+5K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+5K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+5K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+5K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+5K121213VitreaadvancedVital Images, Inc.201281
+5K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+5K082775Prescision OptionSiemens Medical Solutions USA, Inc.20099—
+5K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+5K082005Modification to HI-Art Treatment SystemTomotherapy Incorporated2008137
+5K071086Resolutionmd Cardiac Product Family, Model: Release 1.0Calgary Scientific, Inc.20070—
+5K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+6K260086CadAI-B DxBeamWorks, Inc.20260—
+6K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+6K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+6K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+6K250416GBrain MRIGalileo Cds, Inc.20251—
+6K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+6K243189TumorSight VizSimBioSys, Inc.20241—
+6K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+6K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+6K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+6K240740qCT LN QuantQure.Ai Technologies20240—
+6K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+6K231662Aid-UIaid20241—
+6K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K230023ART-PlanTherapanacea Sas20233—
+6K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+6K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—