510(k) Report

Devices descending from K191157

10 later devices reach uMR 780, uMR 790 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193176uMR 780Shanghai United Imaging Healthcare Co., Ltd.20200—
+1K193200uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20208—
+2K220332uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd.20227—
+3K243122uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20252—
+3K230152uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20236—
+4K243547uMR UltraShanghai United Imaging Healthcare Co., Ltd.20251—
+4K233673uMR JupiterShanghai United Imaging Healthcare Co., Ltd.20241—
+4K240540uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20243—
+5K260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.20260—
+5K250246uMR JupiterShanghai United Imaging Healthcare Co., Ltd.20250—