510(k) Report

Devices descending from K193200

8 later devices reach uMR Omega through their predicates, nearest generation first.

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