510(k) Report

Devices descending from K010042

214 later devices reach CT Perfusion 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052839CT Perfusion 4GE Healthcare2006431
+1K050867Syngo Body Perfusion-CTSiemens AG2005192—
+1K043350Mistar, Model V3.2Apollo Medical Imaging Technology Pty., Ltd.200412—
+1K033832Syngo Perfusion-CTSiemens AG Medical Solutions2003194—
+1K013214Cerebral Blood Flow Analysis System (CBP), Model Number CSCP-001AToshiba America Medical Systems, In.C20010—
+2K193289FastStroke, CT Perfusion 4DGE Medical Systems SCS20201—
+2K151212Ziostation2Qi Imaging, LLC20152—
+2K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+2K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+2K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+2K073238Syngo Volume Perfusion-CT NeuroSiemens AG Medical Solutions200819—
+2K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+2K063507Syngo Neuro PBV CTSiemens AG20060—
+2K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc.2006169—
+2K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+3K251484CT:VQ4Dmedical Limited20250—
+3K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+3K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+3K123541Syngo.CT Neuro PerfusionSiemens Medical Systems, Inc.20132—
+3K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+3K121213VitreaadvancedVital Images, Inc.201281
+3K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+3K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions20096—
+3K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+3K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc.2008168—
+4K220349TeraRecon NeuroTerarecon,Inc.20220—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+4K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+4K163284syngo. CT Neuro PerfusionSiemens Medical Solutions USA, Inc.20171—
+4K153289HealthmyneHealthmyne, Inc.20160—
+4K150713syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc.20151—
+4K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+4K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+4K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+4K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+4K081556Cadstream, Version 5.0Confirma, Inc.20099—
+5K202213syngo.CT Neuro PerfusionSiemens Medical Solutions USA, Inc.20200—
+5K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+5K170195QuantXQuantitative Insights, Inc.20174—
+5K161201ClearRead CTRiverain Technologies, LLC20165—
+5K151988Visible Patient SuiteVisible Patient, Sas20154—
+5K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+5K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+5K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+5K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+5K133521Aze Phoenix SoftwareAze, Ltd.20140—
+5K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+5K113620Myrian 1.11Intrasense20126—
+5K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+5K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+5K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+5K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+5K092954Cadstream Version 5Confirma, Inc.200983
+6K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+6K242919V5med Lung AIV5med, Inc.20250—
+6K231130TumorSight VizSimBioSys, Inc.20232—
+6K221612ClearRead CTRiverain Technologies, Inc.20220—
+6K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+6K210670BU-CADTaihao Medical, Inc.20213—
+6K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+6K212896Visible Patient SuiteVisible Patient, Sas20213—
+6K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+6K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+6K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+6K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+6K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+6K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+6K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+6K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+6K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+6K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+6K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+6K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+6K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+6K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+6K123920Syngo.ViaSiemens AG Medical Solutions201363—
+6K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+7K260086CadAI-B DxBeamWorks, Inc.20260—
+7K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+7K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+7K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+7K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+7K243189TumorSight VizSimBioSys, Inc.20241—
+7K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+7K233457RUSHutom, Inc.20240—
+7K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+7K223261Open RibCanon Medical Informatics, Inc.20230—
+7K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+7K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K211655aPROMISEExini Diagnostics AB20211—
+7K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+7K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+7K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—