510(k) Report

Devices descending from K940172

119 later devices reach Cardiovascular Measurement System-CMS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993763Quantitative Analysis of Coronary Angiograms (Qca)Medis Medical Imaging Systems BV199948—
+1K993765Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV1999113—
+2K112807X-Ray VvaMedis Medical Imaging Systems BV20122—
+2K073328Cardiop-B System, Version 2.1 with LvaPaieon, Inc.200837—
+2K072591Cardiop-B System, Version 2.1Paieon, Inc.200738—
+2K030139The Cardiop-B SystemPaieon, Inc.200440—
+2K034059Sectra Angiography Package and Sectra Cardiology PackageSectra AB20042—
+2K023970Quantitative Vascular Angiography - CMSMedis Medical Imaging Systems BV20036—
+2K994283Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV200068—
+3K222036MPXA-2000Medipixel, Inc.20231—
+3K090833SegmentMedviso200913—
+3K082526Cardio Vue Quantitative Analysis (CVQ)Mri Cardiac Services, Incorporated20090—
+3K082628CMR42 Cardiac Mri Imaging System, 2.1.23Circle Cardiovascular Imaging, Inc.200812—
+3K082907IC-Pro System, Version 3.1.0.4Paieon, Inc.200836—
+3K082706Infinitt Cardiology PacsInfinitt Co., Ltd.20080—
+3K073194Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia ToolsCardiovascular Imaging Solutions, Ltd.200828—
+3K060483Volcano Angio-Ivus Mapping (Aim) SystemVolcano Corporation200631—
+3K060941Caas MRV Version 3.0Pie Medical Imaging BV20064—
+3K043271R2-Mri Analysis SystemInner Vision Biometrics Pty, Ltd.20057—
+3K042781Ipacs CardioRealtimeimage, Inc.20041—
+3K041682Caas MRVPie Medical Imaging BV20041—
+3K031927GE Delta Software Option for MriGE Medical Systems200322—
+4K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+4K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+4K222854iTFlowCardio Flow Design, Inc.20231—
+4K213960LiverMultiScan v5 (LMSv5)Perspectum20221—
+4K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc.20227—
+4K211432Myomics QPhantomics, Inc.20211—
+4K163076Segment CMRMedviso AB20172—
+4K162112Caas MRVPie Medical Imaging BV20162—
+4K151780CAAS WorkstationPie Medical Imaging BV20169—
+4K140587MR-CT VvaMedis Medical Imaging Systems BV201519—
+4K122035Hepafat ScanResonance Health Analysis Services Pty, Ltd.20133—
+4K121762Cardiac VXGe Medical Systems, LLC2013211
+4K113620Myrian 1.11Intrasense20126—
+4K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+4K111222Mri-Q SystemResonance Health Analysis Services Pty, Ltd.20110—
+4K102534Aze Virtualplace-MR Flow Analysis SoftwareAze, Ltd.20110—
+4K100849Sync-RX System, Model AS00010Sync-Rx, Ltd.20104—
+4K090155Caas MR Flow 1.0Pie Medical Imaging BV20092—
+4K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+4K082510Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D…Tomtec Imaging Systems GmbH20080—
+5K260811Heartvue.ProtonHeartvue.ai, Inc.20260—
+5K253413LiverMultiScan (v6.0)Perspectum, Ltd.20260—
+5K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+5K243038Salix CentralArtrya Limited20251—
+5K241922MyomicsPhantomics, Inc.20250—
+5K2420621CMR ProMycardium AI Limited20240—
+5K241312TeraRecon Cardiac.Chambers.MR (1.0.0)Terarecon,Inc.20240—
+5K240385VINTMediimg Corporation20240—
+5K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+5K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd.20230—
+5K211611QIR SuiteCasis Cardiac Simulation & Imaging Software20220—
+5K201039HepaFat-AIResonance Health Analysis Services Pty, Ltd.20202—
+5K191125ADAS 3DGalgo Medical S.L20205—
+5K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K180916iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc.20180—
+5K180019CAAS WorkstationPie Medical Imaging BV20188—
+5K163253Arterys Cardio DLArterys, Inc.20174—
+5K162513Arterys Software v2.0Arterys, Inc.20165—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+5K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+5K132558Sync-RX SystemVolcano Corporation201331
+5K130228SuiteheartNeosoft, LLC20130—
+5K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+5K110256The IC-Pro SystemPaieon, Inc.201115—
+5K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+5K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+5K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+6K251355X1-FFRSpectrawave, Inc.20250—
+6K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+6K232147CAAS WorkstationPie Medical Imaging BV20241—
+6K213776LiverSmartResonance Health Analysis Services Pty, Ltd.20210—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K210850ADAS 3DAdas3D Medical S.L.20214—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+6K182034Arterys MICAArterys, Inc.20183—
+6K151904SyncVision SystemVolcano Corporation201521
+6K151233MonacoImpac Medical Systems, Inc.201569
+6K133993Caas WorkstationPie Medical Imaging201410—
+6K120282CardnavPaieon, Inc.20120—
+6K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+6K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+6K113594C-THV SystemPaieon, Inc.20120—
+6K113076Caas a-ValvePie Medical Imaging BV20121—
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K243769QFR (3.0)Qfr Solutions BV20250—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+7K212421ADAS 3DAdas3D Medical S.L.20213—
+7K192437Arterys MICAArterys, Inc.20202—
+7K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+7K183037Monaco RTP SystemElekta, Inc.201856
+7K161756SyncVision SystemVolcano Corporation201611
+7K143044CAAS A-ValvePie Medical Imaging BV20150—
+7K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+7K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—