510(k) Report

Devices descending from K181830

5 later devices reach Azurion R2.0 through their predicates, nearest generation first.

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