510(k) Report

Devices descending from K994282

73 later devices reach Mri- Flow Analytical Software Package through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102534Aze Virtualplace-MR Flow Analysis SoftwareAze, Ltd.20110—
+1K091262MR Cardiac Function AnalysisZiosoft, Inc.200921—
+1K090155Caas MR Flow 1.0Pie Medical Imaging BV20092—
+1K090833SegmentMedviso200913—
+1K082526Cardio Vue Quantitative Analysis (CVQ)Mri Cardiac Services, Incorporated20090—
+1K082628CMR42 Cardiac Mri Imaging System, 2.1.23Circle Cardiovascular Imaging, Inc.200812—
+1K031927GE Delta Software Option for MriGE Medical Systems200322—
+2K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+2K222854iTFlowCardio Flow Design, Inc.20231—
+2K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc.20227—
+2K211432Myomics QPhantomics, Inc.20211—
+2K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+2K163076Segment CMRMedviso AB20172—
+2K121762Cardiac VXGe Medical Systems, LLC2013211
+2K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+2K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc.201120—
+3K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+3K243038Salix CentralArtrya Limited20251—
+3K241922MyomicsPhantomics, Inc.20250—
+3K2420621CMR ProMycardium AI Limited20240—
+3K241312TeraRecon Cardiac.Chambers.MR (1.0.0)Terarecon,Inc.20240—
+3K240385VINTMediimg Corporation20240—
+3K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+3K211611QIR SuiteCasis Cardiac Simulation & Imaging Software20220—
+3K140587MR-CT VvaMedis Medical Imaging Systems BV201519—
+3K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+3K130228SuiteheartNeosoft, LLC20130—
+3K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+3K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+4K260811Heartvue.ProtonHeartvue.ai, Inc.20260—
+4K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+4K191125ADAS 3DGalgo Medical S.L20205—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K180916iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc.20180—
+4K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+4K163253Arterys Cardio DLArterys, Inc.20174—
+4K162513Arterys Software v2.0Arterys, Inc.20165—
+4K162112Caas MRVPie Medical Imaging BV20162—
+4K151233MonacoImpac Medical Systems, Inc.201569
+4K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+5K210850ADAS 3DAdas3D Medical S.L.20214—
+5K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K183037Monaco RTP SystemElekta, Inc.201856
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K182034Arterys MICAArterys, Inc.20183—
+5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+6K220039AutoSegAi Medic, Inc.20221—
+6K220727inHEART MODELSInheart, Sas20221—
+6K212421ADAS 3DAdas3D Medical S.L.20213—
+6K192437Arterys MICAArterys, Inc.20202—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K190178Monaco RTP SystemElekta, Inc.201945
+7K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+7K231683inHEART ModelsInheart, Sas20240—
+7K230803ADAS 3DAdas3D Medical S.L.20232—
+7K203744Arterys MICAArterys, Inc.20221—
+7K202789Monaco Rtp SystemElekta Solutions AB20213—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+8K252539Tempus PixelArterys, Inc.20250—
+8K240791ADAS 3DAdas3D Medical S.L.20241—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K213787Monaco RTP SystemElekta Solutions AB20222—
+9K253969ADAS 3DAdas3D Medical S.L.20260—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K223233Monaco RTP SystemElekta Solutions AB20231—
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+10K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—