FDA 510(k) Applications Submitted by Gao Xin
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K230039 |
01/06/2023 |
uOmnispace |
Shanghai United Imaging Healthcare Co., Ltd |
| K241068 |
04/19/2024 |
uDR 780i |
Shanghai United Imaging Healthcare Co., Ltd. |
| K241166 |
04/26/2024 |
uCT 550 |
Shanghai United Imaging Healthcare Co., Ltd. |
| K251839 |
06/16/2025 |
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) |
Shanghai United Imaging Healthcare Co., Ltd. |
| K233176 |
09/28/2023 |
uOmnispace.MI |
Shanghai United Imaging Healthcare Co., Ltd. |
| K233186 |
09/28/2023 |
uOmnispace.MR |
Shanghai United Imaging Healthcare Co., Ltd. |
| K233209 |
09/28/2023 |
uOmnispace.CT |
Shanghai United Imaging Healthcare Co., Ltd. |
| K243122 |
09/30/2024 |
uMR Omega |
Shanghai United Imaging Healthcare Co., Ltd. |
| K243397 |
10/31/2024 |
uMR 680 |
Shanghai United Imaging Healthcare Co., Ltd. |
| K243538 |
11/15/2024 |
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) |
Shanghai United Imaging Healthcare Co.,Ltd. |
| K243547 |
11/15/2024 |
uMR Ultra |
Shanghai United Imaging Healthcare Co., Ltd. |
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