510(k) Report

Devices descending from K031333

113 later devices reach Philips Integris Allura Flat Detector Release 1.2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041949Allura Xper FD10Philips Medical Systems North America Co.20046448
+1K031836Philips Fresco Release 1Philips Medical Systems North America Co.200351—
+2K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+2K130842Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura…Philips Medical Systems Nederland B.V.20130Class I
+2K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+2K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+2K092713Spectre Wireless Encrypted Footswitch and Hand Switch SystemTransamerican Medical Imaging201001
+2K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+2K082907IC-Pro System, Version 3.1.0.4Paieon, Inc.200836—
+2K062650EP Navigator SoftwarePhilips Medical Systems200649—
+3K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+3K163622Lung VisionBodyvision Medical, Ltd.20176—
+3K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+3K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+3K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+3K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+3K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+3K100849Sync-RX System, Model AS00010Sync-Rx, Ltd.20104—
+3K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+4K243884TavipilotCaranx Medical20250—
+4K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+4K172418OpenSightNovarad Corporation20185—
+4K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+4K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+4K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+4K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+4K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+4K132558Sync-RX SystemVolcano Corporation201331
+4K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+4K110256The IC-Pro SystemPaieon, Inc.201115—
+4K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+4K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+5K220146VisARNovarad Corporation20220—
+5K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+5K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+5K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+5K151904SyncVision SystemVolcano Corporation201521
+5K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+5K133993Caas WorkstationPie Medical Imaging201410—
+5K120282CardnavPaieon, Inc.20120—
+5K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+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—
+6K243069Lumys (V1)Intradys20250—
+6K232189OrionXRHoth Intelligence, Inc.20230—
+6K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+6K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+6K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+6K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+6K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+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
+7K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+7K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+7K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+7K180019CAAS WorkstationPie Medical Imaging BV20188—
+7K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+7K172574SyncVision SystemVolcano Corporation201701
+8K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+8K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+8K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+8K251355X1-FFRSpectrawave, Inc.20250—
+8K232147CAAS WorkstationPie Medical Imaging BV20241—
+8K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+8K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+8K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+8K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+8K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+9K251827Azurion R3.1Philips Medical Systems B.V.20251—
+9K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+9K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+9K243769QFR (3.0)Qfr Solutions BV20250—
+9K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+9K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+9K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+10K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+10K254186Azurion R3.1Philips Medical Systems B.V.20260—
+10K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+10K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+10K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+10K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+10K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+11K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+11K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+12K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+12K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+12K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+13K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—