510(k) Report

Devices descending from K041949

64 later devices reach Allura Xper FD10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+1K130842Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura…Philips Medical Systems Nederland B.V.20130Class I
+1K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+1K092713Spectre Wireless Encrypted Footswitch and Hand Switch SystemTransamerican Medical Imaging201001
+1K082907IC-Pro System, Version 3.1.0.4Paieon, Inc.200836—
+2K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+2K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+2K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+2K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+2K100849Sync-RX System, Model AS00010Sync-Rx, Ltd.20104—
+2K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+3K243884TavipilotCaranx Medical20250—
+3K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+3K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+3K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+3K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+3K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+3K132558Sync-RX SystemVolcano Corporation201331
+3K110256The IC-Pro SystemPaieon, Inc.201115—
+3K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+3K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+3K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+4K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+4K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+4K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+4K151904SyncVision SystemVolcano Corporation201521
+4K133993Caas WorkstationPie Medical Imaging201410—
+4K120282CardnavPaieon, Inc.20120—
+4K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+4K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+4K113594C-THV SystemPaieon, Inc.20120—
+4K113076Caas a-ValvePie Medical Imaging BV20121—
+5K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+5K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+5K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+5K161756SyncVision SystemVolcano Corporation201611
+5K151780CAAS WorkstationPie Medical Imaging BV20169—
+5K143044CAAS A-ValvePie Medical Imaging BV20150—
+5K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+5K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+6K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+6K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+6K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+6K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+6K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+6K180019CAAS WorkstationPie Medical Imaging BV20188—
+6K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+6K172574SyncVision SystemVolcano Corporation201701
+7K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+7K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+7K251355X1-FFRSpectrawave, Inc.20250—
+7K232147CAAS WorkstationPie Medical Imaging BV20241—
+7K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+7K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+7K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+8K251827Azurion R3.1Philips Medical Systems B.V.20251—
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+8K243769QFR (3.0)Qfr Solutions BV20250—
+8K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+9K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+9K254186Azurion R3.1Philips Medical Systems B.V.20260—
+9K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+9K221711AccuICASArteryFlow Technology Co., Ltd.20230—