510(k) Report

Devices descending from K960635

211 later devices reach Pulmo CT with Reference Database for the Somatom Plus and Plus 4 Computed… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions2007210—
+2K123540Syngo CT Pulmo 3DSiemens Medical Systems, Inc.20139—
+2K113715Lung Volume AnalysisToshibamedical Systems Corporation20120—
+2K103480Thoracic VcarGe Medical Systems, LLC20114—
+2K083227Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc.200849—
+2K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc.2008168—
+3K223071Xenoview VDPPolarean, Inc.20220—
+3K203783ClariPulmoClaripi, Inc.20220—
+3K220450syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20221—
+3K200990VIDAvisionVida Diagnostics, Inc.20202—
+3K191550BroncholabFluidda, Inc.20200—
+3K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+3K183210Thoracic VCAR with GSI Pulmonary PerfusionGE Medical Systems SCS20190—
+3K173821LungQ SoftwareThirona Corporation20183—
+3K151919Vitrea CT Lung Density Analysis SoftwareVital Images, Inc.201510—
+3K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+3K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation20150—
+3K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+3K130542Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.20139—
+3K121449DirectpathCybernet Systems Co., Ltd.20120—
+3K120648Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.201210—
+3K093810BF-NaviKgt, Inc.20101—
+3K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+3K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+4K233875Brainomix 360 e-LungBrainomix Limited20241—
+4K232412LungQ v3.0.0Thirona BV20241—
+4K232136syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20240—
+4K232392CT Lung Ventilation Analysis Software (CT:V)4Dmedical Limited20231—
+4K223556DeepCatchMedical IP Co., Ltd.20231—
+4K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+4K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+4K212494Lung Image AnalysisPulmonx Corporation20210—
+4K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+4K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+4K171199AVIEWCoreline Soft Co., Ltd.20186—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K161201ClearRead CTRiverain Technologies, LLC20165—
+4K151988Visible Patient SuiteVisible Patient, Sas20154—
+4K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+4K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+4K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+4K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+4K133521Aze Phoenix SoftwareAze, Ltd.20140—
+4K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+4K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+4K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+4K113620Myrian 1.11Intrasense20126—
+4K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+4K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+4K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+4K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+5K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+5K253944Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated20260—
+5K250766LungQ 4Thirona BV20250—
+5K251484CT:VQ4Dmedical Limited20250—
+5K242919V5med Lung AIV5med, Inc.20250—
+5K242411Brainomix 360 e-LungBrainomix Limited20250—
+5K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+5K212896Visible Patient SuiteVisible Patient, Sas20213—
+5K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+5K200714AVIEWCoreline Soft Co., Ltd.20205—
+5K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+5K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+5K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+5K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+5K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+5K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+5K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+5K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+5K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+5K123920Syngo.ViaSiemens AG Medical Solutions201363—
+5K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+6K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+6K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+6K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+6K233457RUSHutom, Inc.20240—
+6K223261Open RibCanon Medical Informatics, Inc.20230—
+6K214036AVIEWCoreline Soft Co., Ltd.20224—
+6K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+6K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+6K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+6K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+6K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+6K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+6K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+6K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+6K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+6K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+6K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+6K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711