510(k) Report

Devices descending from K043469

218 later devices reach Syngo Inspace 4D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+1K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions2007210—
+1K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc.2006169—
+1K062673Modification to Syngo Inspace 4DSiemens AG Medical Solutions2006172—
+1K053024Syngo Neuro Dsa CTSiemens AG20058—
+2K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+2K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+2K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+2K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+2K123540Syngo CT Pulmo 3DSiemens Medical Systems, Inc.20139—
+2K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+2K123920Syngo.ViaSiemens AG Medical Solutions201363—
+2K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+2K113715Lung Volume AnalysisToshibamedical Systems Corporation20120—
+2K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+2K111079Syngo.Via Web ViewerSiemens AG Medical Solutions20111—
+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—
+2K063507Syngo Neuro PBV CTSiemens AG20060—
+3K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+3K223261Open RibCanon Medical Informatics, Inc.20230—
+3K223071Xenoview VDPPolarean, Inc.20220—
+3K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+3K203783ClariPulmoClaripi, Inc.20220—
+3K220450syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20221—
+3K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+3K200990VIDAvisionVida Diagnostics, Inc.20202—
+3K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+3K191550BroncholabFluidda, Inc.20200—
+3K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+3K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+3K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+3K183210Thoracic VCAR with GSI Pulmonary PerfusionGE Medical Systems SCS20190—
+3K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+3K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+3K173821LungQ SoftwareThirona Corporation20183—
+3K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+3K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+3K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+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—
+3K150843syngo®.via (version VB10A)Siemens AG201546—
+3K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+3K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+3K130998Syngo.Via Web ViewerSiemens AG Medical Solutions20140—
+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—
+4K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+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—
+4K223424Spine Auto ViewsGE Medical Systems SCS20230—
+4K223556DeepCatchMedical IP Co., Ltd.20231—
+4K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+4K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+4K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+4K213944HealthOSTNanoxai, Ltd.20221—
+4K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+4K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+4K212494Lung Image AnalysisPulmonx Corporation20210—
+4K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+4K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+4K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+4K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+4K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+4K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+4K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+4K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+4K171199AVIEWCoreline Soft Co., Ltd.20186—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+4K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+4K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+4K161201ClearRead CTRiverain Technologies, LLC20165—
+4K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+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—
+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—
+5K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+5K253944Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated20260—
+5K250766LungQ 4Thirona BV20250—
+5K251484CT:VQ4Dmedical Limited20250—
+5K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+5K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—