510(k) Report

Devices descending from K182237

3 later devices reach uMI 550 PET/CT System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193210Hyper DLRShanghai United Imaging Healthcare Co., Ltd.20200—
+1K193241Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.202016
+2K210001HYPER AiRShanghai United Imaging Healthcare Co., Ltd.20210—