510(k) Report

Devices descending from K993765

113 later devices reach Quantitative Analysis of Left Ventricular Angiograms (QLV) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112807X-Ray VvaMedis Medical Imaging Systems BV20122—
+1K073328Cardiop-B System, Version 2.1 with LvaPaieon, Inc.200837—
+1K034059Sectra Angiography Package and Sectra Cardiology PackageSectra AB20042—
+1K994283Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV200068—
+2K222036MPXA-2000Medipixel, Inc.20231—
+2K090833SegmentMedviso200913—
+2K082526Cardio Vue Quantitative Analysis (CVQ)Mri Cardiac Services, Incorporated20090—
+2K082628CMR42 Cardiac Mri Imaging System, 2.1.23Circle Cardiovascular Imaging, Inc.200812—
+2K082907IC-Pro System, Version 3.1.0.4Paieon, Inc.200836—
+2K082706Infinitt Cardiology PacsInfinitt Co., Ltd.20080—
+2K073194Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia ToolsCardiovascular Imaging Solutions, Ltd.200828—
+2K060941Caas MRV Version 3.0Pie Medical Imaging BV20064—
+2K043271R2-Mri Analysis SystemInner Vision Biometrics Pty, Ltd.20057—
+2K042781Ipacs CardioRealtimeimage, Inc.20041—
+2K041682Caas MRVPie Medical Imaging BV20041—
+2K031927GE Delta Software Option for MriGE Medical Systems200322—
+3K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+3K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+3K222854iTFlowCardio Flow Design, Inc.20231—
+3K213960LiverMultiScan v5 (LMSv5)Perspectum20221—
+3K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc.20227—
+3K211432Myomics QPhantomics, Inc.20211—
+3K163076Segment CMRMedviso AB20172—
+3K162112Caas MRVPie Medical Imaging BV20162—
+3K140587MR-CT VvaMedis Medical Imaging Systems BV201519—
+3K122035Hepafat ScanResonance Health Analysis Services Pty, Ltd.20133—
+3K121762Cardiac VXGe Medical Systems, LLC2013211
+3K113620Myrian 1.11Intrasense20126—
+3K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+3K111222Mri-Q SystemResonance Health Analysis Services Pty, Ltd.20110—
+3K102534Aze Virtualplace-MR Flow Analysis SoftwareAze, Ltd.20110—
+3K100849Sync-RX System, Model AS00010Sync-Rx, Ltd.20104—
+3K090155Caas MR Flow 1.0Pie Medical Imaging BV20092—
+3K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+3K082510Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D…Tomtec Imaging Systems GmbH20080—
+4K260811Heartvue.ProtonHeartvue.ai, Inc.20260—
+4K253413LiverMultiScan (v6.0)Perspectum, Ltd.20260—
+4K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+4K243038Salix CentralArtrya Limited20251—
+4K241922MyomicsPhantomics, Inc.20250—
+4K2420621CMR ProMycardium AI Limited20240—
+4K241312TeraRecon Cardiac.Chambers.MR (1.0.0)Terarecon,Inc.20240—
+4K240385VINTMediimg Corporation20240—
+4K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+4K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd.20230—
+4K211611QIR SuiteCasis Cardiac Simulation & Imaging Software20220—
+4K201039HepaFat-AIResonance Health Analysis Services Pty, Ltd.20202—
+4K191125ADAS 3DGalgo Medical S.L20205—
+4K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K180916iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc.20180—
+4K163253Arterys Cardio DLArterys, Inc.20174—
+4K162513Arterys Software v2.0Arterys, Inc.20165—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+4K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+4K132558Sync-RX SystemVolcano Corporation201331
+4K130228SuiteheartNeosoft, LLC20130—
+4K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+4K110256The IC-Pro SystemPaieon, Inc.201115—
+4K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+4K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+4K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+5K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+5K213776LiverSmartResonance Health Analysis Services Pty, Ltd.20210—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K210850ADAS 3DAdas3D Medical S.L.20214—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K182034Arterys MICAArterys, Inc.20183—
+5K151904SyncVision SystemVolcano Corporation201521
+5K151233MonacoImpac Medical Systems, Inc.201569
+5K133993Caas WorkstationPie Medical Imaging201410—
+5K120282CardnavPaieon, Inc.20120—
+5K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+5K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+5K113594C-THV SystemPaieon, Inc.20120—
+5K113076Caas a-ValvePie Medical Imaging BV20121—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K212421ADAS 3DAdas3D Medical S.L.20213—
+6K192437Arterys MICAArterys, Inc.20202—
+6K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+6K183037Monaco RTP SystemElekta, Inc.201856
+6K161756SyncVision SystemVolcano Corporation201611
+6K151780CAAS WorkstationPie Medical Imaging BV20169—
+6K143044CAAS A-ValvePie Medical Imaging BV20150—
+6K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+6K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+7K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+7K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+7K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+7K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+7K230803ADAS 3DAdas3D Medical S.L.20232—
+7K203744Arterys MICAArterys, Inc.20221—
+7K190178Monaco RTP SystemElekta, Inc.201945
+7K180019CAAS WorkstationPie Medical Imaging BV20188—
+7K172574SyncVision SystemVolcano Corporation201701
+8K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+8K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+8K251355X1-FFRSpectrawave, Inc.20250—
+8K252539Tempus PixelArterys, Inc.20250—