510(k) Report

Devices descending from K002016

76 later devices reach Philips Integris Allura through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+1K033737Allura Xper FD20Philips Medical Systems North America, Inc.200326Class I
+1K031836Philips Fresco Release 1Philips Medical Systems North America Co.200351—
+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—
+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—
+2K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+2K062650EP Navigator SoftwarePhilips Medical Systems200649—
+3K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+3K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+3K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+3K163622Lung VisionBodyvision Medical, Ltd.20176—
+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
+3K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+3K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+4K243884TavipilotCaranx Medical20250—
+4K172418OpenSightNovarad Corporation20185—
+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—
+4K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+4K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+5K220146VisARNovarad Corporation20220—
+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
+5K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+5K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+6K243069Lumys (V1)Intradys20250—
+6K232189OrionXRHoth Intelligence, Inc.20230—
+6K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+6K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+6K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+6K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+7K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+7K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+7K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+7K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+8K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+8K251827Azurion R3.1Philips Medical Systems B.V.20251—
+8K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+8K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+8K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+9K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+9K254186Azurion R3.1Philips Medical Systems B.V.20260—
+9K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+9K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+10K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+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—
+13K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+13K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+13K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+13K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+13K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+14K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+14K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+14K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+14K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+15K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+15K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+15K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+16K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—