510(k) Report

Devices descending from K172143

16 later devices reach uMI 780 PET/CT System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241596uMI PanvivoShanghai United Imaging Healthcare Co., Ltd.202451
+1K223325uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202332
+1K193210Hyper DLRShanghai United Imaging Healthcare Co., Ltd.20200—
+1K182938Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.201811
+1K182237uMI 550 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.2018310
+2K243538uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202441
+2K231762uEXPLORERShanghai United Imaging Healthcare Co., Ltd.202401
+2K232712uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202302
+2K231572uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202311
+2K193241Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd.202016
+3K251839uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.202532
+3K241585uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.202401
+3K210001HYPER AiRShanghai United Imaging Healthcare Co., Ltd.20210—
+4K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.20260—
+4K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…Shanghai United Imaging Healthcare Co., Ltd.20261—
+5K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…Shanghai United Imaging Healthcare Co., Ltd.20260—