510(k) Report

Devices descending from K013381

470 later devices reach Advanced Lung Analysis-1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042694Advanced Lung Analysis IIGE Medical Systems2004207—
+1K041807Lung Car 1.1Medicsight2004135—
+1K040028CA-1500R2 Technology, Inc.20044—
+1K033412Mediclung, Release 1Medicsight2003136—
+1K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc.20031702
+1K024149PrimelungAccuimage Diagnostics Corp.20031—
+1K022013Lungcare CT Software PackageSiemens Medical Solutions USA, Inc.2002379—
+2K201501VeolityMeVis Medical Solutions AG20210—
+2K120679Synapse 3D Nodule AnalysisFujifilm Medical Systems U.S.A, Inc.20120—
+2K071310Syngo CT Oncology Software PackageSiemens AG2007195—
+2K070868LMS-Lung/TrackMedian Technologies20070—
+2K063324Pet VcarGE Healthcare20072041
+2K063762Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions2007263—
+2K062164Resolutionmd, Version 1.3Calgary Scientific, Inc.20062—
+2K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+2K061214Aquariusaps ServerTerarecon,Inc.2006134—
+2K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+2K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041431
+2K040876Iconnection, Version 3.2.0.0 Medical Image Processing SoftwareVital Images, Inc.200430—
+2K040305VITREA2 Version 3.5Vital Images, Inc.2004164—
+2K033374Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions2003295—
+3K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+3K211247Pet VcarGE Medical Systems SCS20211—
+3K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+3K151212Ziostation2Qi Imaging, LLC20152—
+3K151283Lung Analysis SoftwareVital Images, Inc.20158—
+3K151115MR Core SoftwareVital Images, Inc.20153—
+3K133643Syngo, CT Liver AnalysisSiemens Medi Cal Solutions, Inc.20141—
+3K132853NovapacsNovarad Corp.201462
+3K141302Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc.20142—
+3K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+3K121916IntuitionTerarecon,Inc.201351
+3K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+3K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+3K120484Visia OncologyMeVis Medical Solutions AG20128—
+3K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+3K113541Clearstart SVM SystemIntio, Inc.201171
+3K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+3K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+3K110256The IC-Pro SystemPaieon, Inc.201115—
+3K110366Syngo.CT Cardiac FunctionSiemens AG2011251
+3K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+3K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+3K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+3K100637Syngo.CT Coronary AnalysisSiemens AG Medical Solutions20102—
+3K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101—
+3K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+3K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+3K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+3K083327Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc.200920—
+3K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+3K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+3K062154Vital Connect 4.0Vital Images, Inc.2006124
+3K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20051172
+3K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+3K042408Iqqa-Chest Software PackageEdda Technology, Inc.20040—
+3K041484UndecidedSiemens Medical Solutions USA, Inc.2004222—
+3K041380Imagechecker-CT Software Package with Filling Defect IndicatorR2 Technology, Inc.20043—
+4K2608794DMInvia, LLC20260—
+4K251883MIM – LesionID ProMim Software, Inc.20250—
+4K240786AutoChamberHeartLung Corporation20241—
+4K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+4K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+4K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.20220—
+4K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+4K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+4K200274CariCloudCaristo Diagnostics20200—
+4K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+4K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+4K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+4K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+4K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+4K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+4K160371NovaPACSNovarad Corporation20165—
+4K161201ClearRead CTRiverain Technologies, LLC20165—
+4K161419Multi Modality ViewerVital Images, Inc.20162—
+4K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+4K160150Vitrea CT Colon AnalysisVital Images, Inc.20160—
+4K151887syngo VSimSiemens Medical Solutions USA, Inc.20158—
+4K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+4K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+4K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+4K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+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—
+4K133993Caas WorkstationPie Medical Imaging201410—
+4K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+4K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+4K132523MyoperfusionToshibamedical Systems Corporation201311
+4K130393Mirada RTXMirada Medical, Ltd.201336—
+4K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+4K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+4K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+4K120282CardnavPaieon, Inc.20120—