510(k) Report

Devices descending from K011447

244 later devices reach IN Space 3D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121292Dynapbv Body SoftwareSiemens Medical Solutions USA, Inc.20120—
+1K113027Syngo Aortic Valveguide SoftwareSiemens Medical Solutions USA, Inc.2011151
+1K111052Syngo Neuro PBV-IRSiemens Medical Solutions USA, Inc.20111—
+1K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C201021—
+1K043469Syngo Inspace 4DSiemens AG Medical Solutions2005218—
+2K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+2K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+2K120073Infx-8000V withToshibamedical Systems Corporation2012203
+2K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+2K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions2007210—
+2K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc.2006169—
+2K062673Modification to Syngo Inspace 4DSiemens AG Medical Solutions2006172—
+2K053024Syngo Neuro Dsa CTSiemens AG20058—
+3K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+3K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+3K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+3K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+3K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+3K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+3K133535Infx-8000V, V5.30Toshibamedical Systems Corporation2014102
+3K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+3K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C20138—
+3K123540Syngo CT Pulmo 3DSiemens Medical Systems, Inc.20139—
+3K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+3K123920Syngo.ViaSiemens AG Medical Solutions201363—
+3K113715Lung Volume AnalysisToshibamedical Systems Corporation20120—
+3K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+3K111079Syngo.Via Web ViewerSiemens AG Medical Solutions20111—
+3K103480Thoracic VcarGe Medical Systems, LLC20114—
+3K083227Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc.200849—
+3K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc.2008168—
+3K063507Syngo Neuro PBV CTSiemens AG20060—
+4K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+4K241440HealthCCSngNano-X AI, Ltd.20240—
+4K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+4K223261Open RibCanon Medical Informatics, Inc.20230—
+4K230112CAC SoftwareImbio, Inc.20230—
+4K230223iCAC DeviceBunkerhill, Inc.20236—
+4K223071Xenoview VDPPolarean, Inc.20220—
+4K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+4K203783ClariPulmoClaripi, Inc.20220—
+4K220450syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20221—
+4K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+4K200990VIDAvisionVida Diagnostics, Inc.20202—
+4K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+4K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+4K191550BroncholabFluidda, Inc.20200—
+4K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+4K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+4K183210Thoracic VCAR with GSI Pulmonary PerfusionGE Medical Systems SCS20190—
+4K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+4K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+4K173821LungQ SoftwareThirona Corporation20183—
+4K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+4K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+4K151919Vitrea CT Lung Density Analysis SoftwareVital Images, Inc.201510—
+4K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+4K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation20150—
+4K150843syngo®.via (version VB10A)Siemens AG201546—
+4K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation201592
+4K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+4K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation20147—
+4K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+4K130998Syngo.Via Web ViewerSiemens AG Medical Solutions20140—
+4K130542Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.20139—
+4K121449DirectpathCybernet Systems Co., Ltd.20120—
+4K120648Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.201210—
+4K093810BF-NaviKgt, Inc.20101—
+4K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+4K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+5K260166Bunkerhill Contrast CACBunkerHill Health20260—
+5K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+5K250662Bunkerhill MACBunkerHill Health20250—
+5K243229Bunkerhill AVCBunkerHill Health20253—
+5K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+5K233875Brainomix 360 e-LungBrainomix Limited20241—
+5K232412LungQ v3.0.0Thirona BV20241—
+5K232136syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20240—
+5K232392CT Lung Ventilation Analysis Software (CT:V)4Dmedical Limited20231—
+5K223424Spine Auto ViewsGE Medical Systems SCS20230—
+5K223556DeepCatchMedical IP Co., Ltd.20231—
+5K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+5K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+5K213944HealthOSTNanoxai, Ltd.20221—
+5K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+5K212494Lung Image AnalysisPulmonx Corporation20210—
+5K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+5K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+5K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+5K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+5K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+5K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+5K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+5K171199AVIEWCoreline Soft Co., Ltd.20186—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+5K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+5K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+5K161201ClearRead CTRiverain Technologies, LLC20165—
+5K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—