510(k) Report

Devices descending from K002519

271 later devices reach Vitrea 2, Version 2.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+1K041286Dynacad V1.0Mri Devices Corp.200417—
+1K040746Mra-CMSMedis Medical Imaging Systems BV20042—
+1K040126Viatronix V3D Colon, Revision 1.3Viatronix, Inc.20042—
+1K033361Viatronix V3D Vascular, Revision 1.0Viatronix, Inc.200322—
+1K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc.20031702
+1K032483Viatronix V3D Explorer, Revision 1.2Viatronix, Inc.200376—
+1K031779CadstreamConfirma, Inc.200319—
+1K031871AutoboneGe Medical Systems Europe200358—
+1K022938Vizdexter Version 2.0; Dextroscope MK8; Dextrobeam MK3Volume Interactions Pte, Ltd.20020—
+1K022789Viatronix V3D ExplorerViatronix, Inc.20020—
+1K020658Viatronix V3D ColonViatronix, Inc.20024—
+1K012563Deep GrayCortechs Labs, Inc.20010—
+2K191959QuantX Breast MRI Biopsy Guidance PluginQlarity Imaging20190—
+2K173744ProFuse CADEigen20181—
+2K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+2K133030Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation201411
+2K123566Synapse 3D Colon AnalysisFujifilm Medical Systems U.S.A, Inc.20130—
+2K122164MR Vessellq XpressGE Medical Systems SCS20120—
+2K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+2K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+2K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+2K081556Cadstream, Version 5.0Confirma, Inc.20099—
+2K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+2K062386Qangio CTMedis Medical Imaging Systems BV20060—
+2K062164Resolutionmd, Version 1.3Calgary Scientific, Inc.20062—
+2K061625AUTOBONE2GE Healthcare20060—
+2K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+2K060779Advance Vessel Analysis IIGE Healthcare200655—
+2K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041431
+2K041020Cadstream Version 3.1Confirma, Inc.20040—
+2K040876Iconnection, Version 3.2.0.0 Medical Image Processing SoftwareVital Images, Inc.200430—
+2K033955RTISTMirada Solutions, Ltd.200475—
+2K040305VITREA2 Version 3.5Vital Images, Inc.2004164—
+2K023943CT ColonographyGe Medical Systems, Inc.20033—
+3K200626VesselIQ XpressGE Medical Systems SCS20210—
+3K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+3K173312ProBx SoftwareHarmonus, Inc.20180—
+3K170195QuantXQuantitative Insights, Inc.20174—
+3K151283Lung Analysis SoftwareVital Images, Inc.20158—
+3K151115MR Core SoftwareVital Images, Inc.20153—
+3K141302Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc.20142—
+3K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+3K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+3K110256The IC-Pro SystemPaieon, Inc.201115—
+3K101228Mirada XDMirada Medical, Ltd.201070—
+3K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101—
+3K092954Cadstream Version 5Confirma, Inc.200983
+3K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+3K090220Colon View, Model CSCV-001AToshibamedical Systems Corporation20090—
+3K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+3K081215VoluminaKjaya Medical, LLC20080—
+3K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+3K062154Vital Connect 4.0Vital Images, Inc.2006124
+3K061418QuantivaTomographix IP, Ltd.20060—
+3K061370Cardiq FusionGE Healthcare200651—
+3K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+3K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20051172
+3K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+3K041270CT Colonography IIGeneral Electric Medical Systems20042—
+4K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+4K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+4K240786AutoChamberHeartLung Corporation20241—
+4K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+4K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+4K231130TumorSight VizSimBioSys, Inc.20232—
+4K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+4K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.20220—
+4K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+4K220779XDMirada Medical, Ltd.20220—
+4K210670BU-CADTaihao Medical, Inc.20213—
+4K190868Cleerly LabsCleerly, Inc.20197—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+4K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+4K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+4K161419Multi Modality ViewerVital Images, Inc.20162—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K160150Vitrea CT Colon AnalysisVital Images, Inc.20160—
+4K133993Caas WorkstationPie Medical Imaging201410—
+4K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+4K120282CardnavPaieon, Inc.20120—
+4K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+4K113594C-THV SystemPaieon, Inc.20120—
+4K113076Caas a-ValvePie Medical Imaging BV20121—
+4K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+4K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+4K113543ONDEMAND3DCybermed, Inc.20119—
+4K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc.201120—
+4K102687Mirada RTMirada Medical, Ltd.201037—
+4K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+4K071086Resolutionmd Cardiac Product Family, Model: Release 1.0Calgary Scientific, Inc.20070—
+4K071362Vital Connect 4.1Vital Images, Inc.2007113
+4K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+5K260086CadAI-B DxBeamWorks, Inc.20260—
+5K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+5K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+5K252029AI-CVDHeartLung Corporation20250—
+5K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+5K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—