FDA 510(k) Applications Submitted by Shanghai United Imaging Healthcare Co.,Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K243538 |
11/15/2024 |
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) |
Shanghai United Imaging Healthcare Co.,Ltd. |
| 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. |
| K172143 |
07/17/2017 |
uMI 780 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. |
| K183144 |
11/13/2018 |
uMC 560i |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K210001 |
01/04/2021 |
HYPER AiR |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K220332 |
02/04/2022 |
uMR Omega with uWS-MR-MRS |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K210418 |
02/11/2021 |
HYPER Focus |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K230758 |
03/20/2023 |
uMR 570 |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K181371 |
05/23/2018 |
uMR 790 |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K241585 |
06/03/2024 |
uMI Panorama |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K201540 |
06/09/2020 |
uMR570 |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K242515 |
08/23/2024 |
uDR 380i Pro |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K243376 |
10/30/2024 |
uAngio AVIVA CX |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K243617 |
11/22/2024 |
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis |
Shanghai United Imaging Healthcare Co.,Ltd. |
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