510(k) Report

Devices descending from K022013

379 later devices reach Lungcare CT Software Package through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071310Syngo CT Oncology Software PackageSiemens AG2007195—
+1K063762Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions2007263—
+1K040028CA-1500R2 Technology, Inc.20044—
+1K033412Mediclung, Release 1Medicsight2003136—
+1K033374Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions2003295—
+1K024149PrimelungAccuimage Diagnostics Corp.20031—
+2K201501VeolityMeVis Medical Solutions AG20210—
+2K133643Syngo, CT Liver AnalysisSiemens Medi Cal Solutions, Inc.20141—
+2K120484Visia OncologyMeVis Medical Solutions AG20128—
+2K113541Clearstart SVM SystemIntio, Inc.201171
+2K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+2K110366Syngo.CT Cardiac FunctionSiemens AG2011251
+2K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+2K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+2K100637Syngo.CT Coronary AnalysisSiemens AG Medical Solutions20102—
+2K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+2K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+2K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+2K083327Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc.200920—
+2K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+2K070868LMS-Lung/TrackMedian Technologies20070—
+2K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+2K042694Advanced Lung Analysis IIGE Medical Systems2004207—
+2K042408Iqqa-Chest Software PackageEdda Technology, Inc.20040—
+2K041484UndecidedSiemens Medical Solutions USA, Inc.2004222—
+2K041807Lung Car 1.1Medicsight2004135—
+2K041380Imagechecker-CT Software Package with Filling Defect IndicatorR2 Technology, Inc.20043—
+3K2608794DMInvia, LLC20260—
+3K240786AutoChamberHeartLung Corporation20241—
+3K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+3K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+3K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+3K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+3K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+3K161201ClearRead CTRiverain Technologies, LLC20165—
+3K151887syngo VSimSiemens Medical Solutions USA, Inc.20158—
+3K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+3K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+3K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+3K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+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—
+3K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+3K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+3K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+3K132523MyoperfusionToshibamedical Systems Corporation201311
+3K130393Mirada RTXMirada Medical, Ltd.201336—
+3K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+3K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+3K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+3K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+3K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+3K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+3K113620Myrian 1.11Intrasense20126—
+3K120679Synapse 3D Nodule AnalysisFujifilm Medical Systems U.S.A, Inc.20120—
+3K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+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—
+3K112531Vitrea CT Myocardial AnalysisVital Images, Inc.20116—
+3K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+3K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+3K110494Syngo MBFSiemens Medical Solutions USA, Inc.20116—
+3K102687Mirada RTMirada Medical, Ltd.201037—
+3K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+3K101228Mirada XDMirada Medical, Ltd.201070—
+3K063324Pet VcarGE Healthcare20072041
+3K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+3K061214Aquariusaps ServerTerarecon,Inc.2006134—
+3K053301Cedara I-Response Cedara Pet/CTCedara Software Corp.2006221—
+4K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+4K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+4K252029AI-CVDHeartLung Corporation20250—
+4K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+4K242919V5med Lung AIV5med, Inc.20250—
+4K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+4K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+4K240620Cube NavigatorMedical Templates AG20240—
+4K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+4K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+4K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+4K221612ClearRead CTRiverain Technologies, Inc.20220—
+4K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+4K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+4K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+4K220779XDMirada Medical, Ltd.20220—
+4K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+4K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+4K211247Pet VcarGE Medical Systems SCS20211—
+4K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+4K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+4K202700ART-PlanTherapanacea20215—
+4K201250SQuEEZ SoftwareCardiowise, Inc.20200—
+4K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+4K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+4K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+4K200323AutoContourRadformation, Inc.20207—
+4K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—