FDA 510(k) Applications Submitted by Shumei Wang
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180925 |
04/09/2018 |
uMR 570 |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K180926 |
04/09/2018 |
uMR 560 |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K181413 |
05/30/2018 |
uDR 592h, uDR 596i |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K181414 |
05/30/2018 |
uCT 530, uCT 550 |
Shanghai United Imaging Healthcare Co., Ltd. |
| K172135 |
07/14/2017 |
uCT Computed Tomography X-ray System |
Shanghai United Imaging Healthcare Co., Ltd. |
| K172143 |
07/17/2017 |
uMI 780 PET/CT System |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K182237 |
08/17/2018 |
uMI 550 PET/CT System |
Shanghai United Imaging Healthcare Co., Ltd. |
| K172998 |
09/27/2017 |
uWS-MI |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K172999 |
09/27/2017 |
uWS-MR |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K173001 |
09/27/2017 |
uWS-CT |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K182938 |
10/23/2018 |
Emission Computed Tomography System |
Shanghai United Imaging Healthcare Co., Ltd. |
| K183014 |
10/31/2018 |
uPMR 790 |
Shanghai United Imaging Healthcare Co., Ltd. |
| K193073 |
11/04/2019 |
Deep Recon |
Shanghai United Imaging Healthcare Co., Ltd. |
| K183143 |
11/13/2018 |
uCT 520, uCT 528 |
Shangai United Imaging Healthcare Co., Ltd. |
| K183144 |
11/13/2018 |
uMC 560i |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K193210 |
11/21/2019 |
HYPER DLR |
Shanghai United Imaging Healthcare Co., Ltd. |
| K193241 |
11/25/2019 |
Emission Computed Tomography System |
Shanghai United Imaging Healthcare Co., Ltd |
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