510(k) Report

Devices descending from K910839

197 later devices reach Ultimate 3000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982536Perfusion CT (Computed Tomography) Software PackageSiemens Corp.1998196—
+2K033832Syngo Perfusion-CTSiemens AG Medical Solutions2003194—
+2K013214Cerebral Blood Flow Analysis System (CBP), Model Number CSCP-001AToshiba America Medical Systems, In.C20010—
+3K073238Syngo Volume Perfusion-CT NeuroSiemens AG Medical Solutions200819—
+3K063507Syngo Neuro PBV CTSiemens AG20060—
+3K050867Syngo Body Perfusion-CTSiemens AG2005192—
+4K123541Syngo.CT Neuro PerfusionSiemens Medical Systems, Inc.20132—
+4K121213VitreaadvancedVital Images, Inc.201281
+4K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+4K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions20096—
+4K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+4K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc.2006169—
+5K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+5K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+5K163284syngo. CT Neuro PerfusionSiemens Medical Solutions USA, Inc.20171—
+5K153289HealthmyneHealthmyne, Inc.20160—
+5K151212Ziostation2Qi Imaging, LLC20152—
+5K150713syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc.20151—
+5K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+5K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+5K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+5K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+5K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+5K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc.2008168—
+6K251484CT:VQ4Dmedical Limited20250—
+6K202213syngo.CT Neuro PerfusionSiemens Medical Solutions USA, Inc.20200—
+6K181892Ziostation2Ziosoft, Inc.20181—
+6K151988Visible Patient SuiteVisible Patient, Sas20154—
+6K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+6K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+6K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+7K212896Visible Patient SuiteVisible Patient, Sas20213—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+7K161201ClearRead CTRiverain Technologies, LLC20165—
+7K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+7K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+7K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+7K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+7K133521Aze Phoenix SoftwareAze, Ltd.20140—
+7K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+7K113620Myrian 1.11Intrasense20126—
+7K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+7K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+7K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+7K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+8K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+8K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+8K242919V5med Lung AIV5med, Inc.20250—
+8K233457RUSHutom, Inc.20240—
+8K221612ClearRead CTRiverain Technologies, Inc.20220—
+8K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+8K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+8K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+8K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+8K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+8K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+8K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+8K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+8K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+8K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+8K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+8K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+8K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+8K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+8K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+8K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+8K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+8K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+8K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+8K123920Syngo.ViaSiemens AG Medical Solutions201363—
+8K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+9K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+9K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+9K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+9K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+9K223261Open RibCanon Medical Informatics, Inc.20230—
+9K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+9K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+9K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+9K211655aPROMISEExini Diagnostics AB20211—
+9K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+9K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+9K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+9K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+9K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+9K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+9K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+9K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+9K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+9K150843syngo®.via (version VB10A)Siemens AG201546—
+9K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+9K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+10K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+10K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+10K223424Spine Auto ViewsGE Medical Systems SCS20230—
+10K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+10K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+10K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+10K220590aPROMISE XExini Diagnostics AB20220—