510(k) Report

Devices descending from K994283

68 later devices reach Mri- Magnetic Resonance Analytical Software System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090833SegmentMedviso200913—
+1K082526Cardio Vue Quantitative Analysis (CVQ)Mri Cardiac Services, Incorporated20090—
+1K082628CMR42 Cardiac Mri Imaging System, 2.1.23Circle Cardiovascular Imaging, Inc.200812—
+1K073194Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia ToolsCardiovascular Imaging Solutions, Ltd.200828—
+1K060941Caas MRV Version 3.0Pie Medical Imaging BV20064—
+1K043271R2-Mri Analysis SystemInner Vision Biometrics Pty, Ltd.20057—
+1K041682Caas MRVPie Medical Imaging BV20041—
+1K031927GE Delta Software Option for MriGE Medical Systems200322—
+2K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+2K222854iTFlowCardio Flow Design, Inc.20231—
+2K213960LiverMultiScan v5 (LMSv5)Perspectum20221—
+2K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc.20227—
+2K211432Myomics QPhantomics, Inc.20211—
+2K163076Segment CMRMedviso AB20172—
+2K162112Caas MRVPie Medical Imaging BV20162—
+2K140587MR-CT VvaMedis Medical Imaging Systems BV201519—
+2K122035Hepafat ScanResonance Health Analysis Services Pty, Ltd.20133—
+2K121762Cardiac VXGe Medical Systems, LLC2013211
+2K113620Myrian 1.11Intrasense20126—
+2K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+2K111222Mri-Q SystemResonance Health Analysis Services Pty, Ltd.20110—
+2K102534Aze Virtualplace-MR Flow Analysis SoftwareAze, Ltd.20110—
+2K090155Caas MR Flow 1.0Pie Medical Imaging BV20092—
+2K082510Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D…Tomtec Imaging Systems GmbH20080—
+3K260811Heartvue.ProtonHeartvue.ai, Inc.20260—
+3K253413LiverMultiScan (v6.0)Perspectum, Ltd.20260—
+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—
+3K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd.20230—
+3K211611QIR SuiteCasis Cardiac Simulation & Imaging Software20220—
+3K201039HepaFat-AIResonance Health Analysis Services Pty, Ltd.20202—
+3K191125ADAS 3DGalgo Medical S.L20205—
+3K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K180916iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc.20180—
+3K163253Arterys Cardio DLArterys, Inc.20174—
+3K162513Arterys Software v2.0Arterys, Inc.20165—
+3K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+3K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+3K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+3K130228SuiteheartNeosoft, LLC20130—
+3K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+4K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+4K213776LiverSmartResonance Health Analysis Services Pty, Ltd.20210—
+4K211655aPROMISEExini Diagnostics AB20211—
+4K210850ADAS 3DAdas3D Medical S.L.20214—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K182034Arterys MICAArterys, Inc.20183—
+4K151233MonacoImpac Medical Systems, Inc.201569
+5K220590aPROMISE XExini Diagnostics AB20220—
+5K212421ADAS 3DAdas3D Medical S.L.20213—
+5K192437Arterys MICAArterys, Inc.20202—
+5K183037Monaco RTP SystemElekta, Inc.201856
+6K230803ADAS 3DAdas3D Medical S.L.20232—
+6K203744Arterys MICAArterys, Inc.20221—
+6K190178Monaco RTP SystemElekta, Inc.201945
+7K252539Tempus PixelArterys, Inc.20250—
+7K240791ADAS 3DAdas3D Medical S.L.20241—
+7K202789Monaco Rtp SystemElekta Solutions AB20213—
+8K253969ADAS 3DAdas3D Medical S.L.20260—
+8K213787Monaco RTP SystemElekta Solutions AB20222—
+9K223233Monaco RTP SystemElekta Solutions AB20231—
+10K252002Monaco RTP System (6.3)Elekta Solutions AB20260—