510(k) Report

Devices descending from K020055

124 later devices reach Philips Integris Allura 9 with FD Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100102CS-Series-FPOmega Medical Imaging, Inc.20108—
+1K022899Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co.20021148
+2K121293CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC20127—
+2K031333Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc.200311325
+3K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC20194—
+3K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOmega Medical Imaging, LLC20181—
+3K041949Allura Xper FD10Philips Medical Systems North America Co.20046448
+3K031836Philips Fresco Release 1Philips Medical Systems North America Co.200351—
+4K212890Nyquist.IQOmega Medical Imaging, LLC20210—
+4K212336Soteria.AIOmega Medical Imaging, LLC20211—
+4K201172CFP-3131, CFP-2222Mx Imaging, Inc.20200—
+4K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™…Omega Medical Imaging, LLC20190—
+4K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+4K130842Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura…Philips Medical Systems Nederland B.V.20130Class I
+4K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+4K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+4K092713Spectre Wireless Encrypted Footswitch and Hand Switch SystemTransamerican Medical Imaging201001
+4K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+4K082907IC-Pro System, Version 3.1.0.4Paieon, Inc.200836—
+4K062650EP Navigator SoftwarePhilips Medical Systems200649—
+5K242488Soteria E-ViewOmega Medical Imaging, LLC20250—
+5K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+5K163622Lung VisionBodyvision Medical, Ltd.20176—
+5K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+5K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+5K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+5K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+5K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+5K100849Sync-RX System, Model AS00010Sync-Rx, Ltd.20104—
+5K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+6K243884TavipilotCaranx Medical20250—
+6K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+6K172418OpenSightNovarad Corporation20185—
+6K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+6K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+6K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+6K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+6K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+6K132558Sync-RX SystemVolcano Corporation201331
+6K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+6K110256The IC-Pro SystemPaieon, Inc.201115—
+6K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+6K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+7K221796Cyware 4H and Cysart 4HAbys Medical20221—
+7K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+7K220146VisARNovarad Corporation20220—
+7K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+7K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+7K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+7K151904SyncVision SystemVolcano Corporation201521
+7K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+7K133993Caas WorkstationPie Medical Imaging201410—
+7K120282CardnavPaieon, Inc.20120—
+7K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+7K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+7K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+7K113594C-THV SystemPaieon, Inc.20120—
+7K113076Caas a-ValvePie Medical Imaging BV20121—
+8K243069Lumys (V1)Intradys20250—
+8K232189OrionXRHoth Intelligence, Inc.20230—
+8K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+8K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+8K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+8K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+8K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+8K161756SyncVision SystemVolcano Corporation201611
+8K151780CAAS WorkstationPie Medical Imaging BV20169—
+8K143044CAAS A-ValvePie Medical Imaging BV20150—
+8K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+8K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+9K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+9K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+9K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+9K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+9K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+9K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+9K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+9K180019CAAS WorkstationPie Medical Imaging BV20188—
+9K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+9K172574SyncVision SystemVolcano Corporation201701
+10K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+10K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+10K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+10K251355X1-FFRSpectrawave, Inc.20250—
+10K232147CAAS WorkstationPie Medical Imaging BV20241—
+10K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+10K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+10K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+10K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+10K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+11K251827Azurion R3.1Philips Medical Systems B.V.20251—
+11K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+11K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+11K243769QFR (3.0)Qfr Solutions BV20250—
+11K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+11K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+11K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+11K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+12K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+12K254186Azurion R3.1Philips Medical Systems B.V.20260—