510(k) Report

Devices descending from K130638

18 later devices reach Alluraclarity Xper FD Series X-Ray System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+1K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+2K243884TavipilotCaranx Medical20250—
+2K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+2K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+3K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+3K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+3K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+4K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+4K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+5K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+5K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+6K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+6K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+7K251827Azurion R3.1Philips Medical Systems B.V.20251—
+7K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+8K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+8K254186Azurion R3.1Philips Medical Systems B.V.20260—