510(k) Report

Devices descending from K993763

48 later devices reach Quantitative Analysis of Coronary Angiograms (Qca) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112807X-Ray VvaMedis Medical Imaging Systems BV20122—
+1K072591Cardiop-B System, Version 2.1Paieon, Inc.200738—
+1K030139The Cardiop-B SystemPaieon, Inc.200440—
+1K034059Sectra Angiography Package and Sectra Cardiology PackageSectra AB20042—
+1K023970Quantitative Vascular Angiography - CMSMedis Medical Imaging Systems BV20036—
+2K222036MPXA-2000Medipixel, Inc.20231—
+2K082706Infinitt Cardiology PacsInfinitt Co., Ltd.20080—
+2K073328Cardiop-B System, Version 2.1 with LvaPaieon, Inc.200837—
+2K060483Volcano Angio-Ivus Mapping (Aim) SystemVolcano Corporation200631—
+2K042781Ipacs CardioRealtimeimage, Inc.20041—
+3K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+3K151780CAAS WorkstationPie Medical Imaging BV20169—
+3K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+3K082907IC-Pro System, Version 3.1.0.4Paieon, Inc.200836—
+4K180019CAAS WorkstationPie Medical Imaging BV20188—
+4K110256The IC-Pro SystemPaieon, Inc.201115—
+4K100849Sync-RX System, Model AS00010Sync-Rx, Ltd.20104—
+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
+5K251355X1-FFRSpectrawave, Inc.20250—
+5K232147CAAS WorkstationPie Medical Imaging BV20241—
+5K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+5K133993Caas WorkstationPie Medical Imaging201410—
+5K132558Sync-RX SystemVolcano Corporation201331
+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—
+6K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+6K243769QFR (3.0)Qfr Solutions BV20250—
+6K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+6K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+6K151904SyncVision SystemVolcano Corporation201521
+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
+7K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+7K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+7K161756SyncVision SystemVolcano Corporation201611
+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—
+8K172574SyncVision SystemVolcano Corporation201701