510(k) Report

Devices descending from K181413

2 later devices reach uDR 592h, uDR 596i through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+2K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—