510(k) Report

Devices descending from K200917

4 later devices reach Azurion R2.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251827Azurion R3.1Philips Medical Systems B.V.20251—
+1K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+2K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+2K254186Azurion R3.1Philips Medical Systems B.V.20260—