510(k) Report

Devices descending from K163715

7 later devices reach Allura Xper R9 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+2K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+2K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+3K251827Azurion R3.1Philips Medical Systems B.V.20251—
+3K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+4K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+4K254186Azurion R3.1Philips Medical Systems B.V.20260—