510(k) Report

Devices descending from K071513

210 later devices reach Inspace 4D Software Package with Extended Functionality through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123540Syngo CT Pulmo 3DSiemens Medical Systems, Inc.20139—
+1K113715Lung Volume AnalysisToshibamedical Systems Corporation20120—
+1K103480Thoracic VcarGe Medical Systems, LLC20114—
+1K083227Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc.200849—
+1K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc.2008168—
+2K223071Xenoview VDPPolarean, Inc.20220—
+2K203783ClariPulmoClaripi, Inc.20220—
+2K220450syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20221—
+2K200990VIDAvisionVida Diagnostics, Inc.20202—
+2K191550BroncholabFluidda, Inc.20200—
+2K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+2K183210Thoracic VCAR with GSI Pulmonary PerfusionGE Medical Systems SCS20190—
+2K173821LungQ SoftwareThirona Corporation20183—
+2K151919Vitrea CT Lung Density Analysis SoftwareVital Images, Inc.201510—
+2K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+2K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation20150—
+2K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+2K130542Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.20139—
+2K121449DirectpathCybernet Systems Co., Ltd.20120—
+2K120648Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.201210—
+2K093810BF-NaviKgt, Inc.20101—
+2K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+2K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+3K233875Brainomix 360 e-LungBrainomix Limited20241—
+3K232412LungQ v3.0.0Thirona BV20241—
+3K232136syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20240—
+3K232392CT Lung Ventilation Analysis Software (CT:V)4Dmedical Limited20231—
+3K223556DeepCatchMedical IP Co., Ltd.20231—
+3K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+3K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+3K212494Lung Image AnalysisPulmonx Corporation20210—
+3K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+3K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+3K171199AVIEWCoreline Soft Co., Ltd.20186—
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K161201ClearRead CTRiverain Technologies, LLC20165—
+3K151988Visible Patient SuiteVisible Patient, Sas20154—
+3K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+3K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+3K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+3K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+3K133521Aze Phoenix SoftwareAze, Ltd.20140—
+3K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+3K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+3K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+3K113620Myrian 1.11Intrasense20126—
+3K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+3K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+3K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+3K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+4K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+4K253944Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated20260—
+4K250766LungQ 4Thirona BV20250—
+4K251484CT:VQ4Dmedical Limited20250—
+4K242919V5med Lung AIV5med, Inc.20250—
+4K242411Brainomix 360 e-LungBrainomix Limited20250—
+4K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+4K221612ClearRead CTRiverain Technologies, Inc.20220—
+4K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+4K212896Visible Patient SuiteVisible Patient, Sas20213—
+4K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+4K200714AVIEWCoreline Soft Co., Ltd.20205—
+4K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+4K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+4K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+4K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+4K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+4K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+4K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+4K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+4K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+5K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+5K233457RUSHutom, Inc.20240—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K214036AVIEWCoreline Soft Co., Ltd.20224—
+5K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+5K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+5K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+5K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+5K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+5K150843syngo®.via (version VB10A)Siemens AG201546—