510(k) Report

Devices descending from K010336

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K160150Vitrea CT Colon AnalysisVital Images, Inc.20160—
+5K151780CAAS WorkstationPie Medical Imaging BV20169—
+5K153289HealthmyneHealthmyne, Inc.20160—
+5K151212Ziostation2Qi Imaging, LLC20152—
+5K150713syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc.20151—
+5K151988Visible Patient SuiteVisible Patient, Sas20154—
+5K151774CARESTREAM Vue MotionCarestream Health, Inc.201541
+5K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K143044CAAS A-ValvePie Medical Imaging BV20150—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+5K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+5K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+5K113620Myrian 1.11Intrasense20126—
+5K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+5K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+5K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+5K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+5K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+5K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+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—
+6K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+6K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+6K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+6K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+6K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+6K251766TumorSight VizSimBioSys, Inc.20250—
+6K243301MapRTVision Rt, Ltd.20250—
+6K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+6K250099Mobius3D (4.1)Varian Medical Systems20250—
+6K242919V5med Lung AIV5med, Inc.20250—
+6K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+6K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+6K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+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—
+6K231662Aid-UIaid20241—
+6K232479ART-PlanTherapanacea20232—
+6K223834AccuCheckManteia Technologies Co., Ltd.20231—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+6K221796Cyware 4H and Cysart 4HAbys Medical20221—
+6K221612ClearRead CTRiverain Technologies, Inc.20220—
+6K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+6K220039AutoSegAi Medic, Inc.20221—
+6K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+6K220727inHEART MODELSInheart, Sas20221—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K213976Contour ProtégéAIMim Software, Inc.20224—
+6K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+6K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+6K210831OnQ NeuroCortechs Labs, Inc.20213—
+6K212896Visible Patient SuiteVisible Patient, Sas20213—
+6K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+6K202990NinesMeasureNines, Inc.20211—
+6K201501VeolityMeVis Medical Solutions AG20210—
+6K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+6K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K193220Aview LCSCoreline Soft Co., Ltd.20201—
+6K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+6K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+6K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+6K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+6K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+6K190178Monaco RTP SystemElekta, Inc.201945
+6K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+6K182034Arterys MICAArterys, Inc.20183—
+6K181892Ziostation2Ziosoft, Inc.20181—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K182230Multi Modality ViewerVital Images, Inc.20180—
+6K180019CAAS WorkstationPie Medical Imaging BV20188—
+6K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+6K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+6K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+6K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+6K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+6K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+6K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+6K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+6K091001Myrian 1.4Intrasense20097—
+6K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+6K071362Vital Connect 4.1Vital Images, Inc.2007113
+6K071331Vitrea Version 4.0Vital Images, Inc.2007821
+6K071000MyrianIntrasense20078—
+6K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+6K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—