510(k) Report

Devices descending from K002519

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+5K243189TumorSight VizSimBioSys, Inc.20241—
+5K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+5K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+5K240740qCT LN QuantQure.Ai Technologies20240—
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K202990NinesMeasureNines, Inc.20211—
+5K201501VeolityMeVis Medical Solutions AG20210—
+5K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+5K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+5K193220Aview LCSCoreline Soft Co., Ltd.20201—
+5K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K163574Multi Modality ViewerVital Images, Inc.20171—
+5K151780CAAS WorkstationPie Medical Imaging BV20169—
+5K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+5K152746Ez3D PlusEwoosoft Co., Ltd.20161—
+5K150738VitreaViewVital Images, Inc.20158—
+5K143044CAAS A-ValvePie Medical Imaging BV20150—
+5K132773Sidexis 4Sirona Dental Systems GmbH20131—
+5K131616EZ3D-I, E3Ewoosoft Co., Ltd.20134—
+5K130393Mirada RTXMirada Medical, Ltd.201336—
+5K113620Myrian 1.11Intrasense20126—
+5K091001Myrian 1.4Intrasense20097—
+5K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+5K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+5K071331Vitrea Version 4.0Vital Images, Inc.2007821
+5K071000MyrianIntrasense20078—
+5K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+6K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+6K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+6K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+6K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+6K250755DS Core DiagnosisDentsply Sirona, Inc.20250—
+6K251766TumorSight VizSimBioSys, Inc.20250—
+6K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+6K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+6K220039AutoSegAi Medic, Inc.20221—
+6K220727inHEART MODELSInheart, Sas20221—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+6K202700ART-PlanTherapanacea20215—
+6K200323AutoContourRadformation, Inc.20207—
+6K201710A View LCSCoreline Soft Co., Ltd.20200—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K190232Synapse PACSFujifilm Corporation2019311
+6K182230Multi Modality ViewerVital Images, Inc.20180—
+6K181572Workflow BoxMirada Medical, Ltd.201825—
+6K180019CAAS WorkstationPie Medical Imaging BV20188—
+6K173475Merge PACSMerge Healthcare Incorporated201712
+6K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+6K163232Vitrea ViewVital Images, Inc.20177—
+6K163668SuitestensaEbit Srl20170—
+6K163071vascuCAPElucid Bioimaging, Inc.20173—
+6K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+6K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+6K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+6K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+6K141329RadspaTelerad Tech Private Limited20140—
+6K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+6K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+6K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+6K121213VitreaadvancedVital Images, Inc.201281
+6K121023Spectrum V.0Intrinsic Medical Imaging20120—
+6K120207VISIAMeVis Medical Solutions AG20120—
+6K120484Visia OncologyMeVis Medical Solutions AG20128—
+6K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+6K083691BonevueMicromri, Inc.20090—
+6K072821Vitrea 4DCTVital Images, Inc.2008171
+7K261210Cleerly PlaqueCleerly, Inc.20260—
+7K260588Cleerly LABSCleerly, Inc.20260—
+7K251355X1-FFRSpectrawave, Inc.20250—
+7K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+7K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+7K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+7K232147CAAS WorkstationPie Medical Imaging BV20241—
+7K231683inHEART ModelsInheart, Sas20240—
+7K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+7K220813Art-PlanTherapanacea20224—
+7K212915MVision AI SegmentationMVision AI20221—
+7K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+7K202928DV. TargetDeepvoxel, Inc.20210—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K193252Contour ProtegeAIMim Software, Inc.20206—
+7K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+7K192455Merge PACSMerge Healthcare Incorporated201904
+7K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+7K190764SurgicalARMedivis, Inc.20196—
+7K183012vascuCAPElucid Bioimaging, Inc.20182—
+7K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+7K181892Ziostation2Ziosoft, Inc.20181—
+7K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+7K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+7K161246Ez3D-i / E3Ewoosoft Co., Ltd.20162—
+7K153289HealthmyneHealthmyne, Inc.20160—
+7K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+7K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—