FDA 510(k) Applications Submitted by Shanghai United Imaging Healthcare Co., Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
| K233209 |
09/28/2023 |
uOmnispace.CT |
Shanghai United Imaging Healthcare Co., Ltd. |
| K233186 |
09/28/2023 |
uOmnispace.MR |
Shanghai United Imaging Healthcare Co., Ltd. |
| K233176 |
09/28/2023 |
uOmnispace.MI |
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. |
| K243547 |
11/15/2024 |
uMR Ultra |
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. |
| K182237 |
08/17/2018 |
uMI 550 PET/CT System |
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. |
| K193210 |
11/21/2019 |
HYPER DLR |
Shanghai United Imaging Healthcare Co., Ltd. |
| K200016 |
01/03/2020 |
uCT 530, uCT 550 |
Shanghai United Imaging Healthcare Co., Ltd. |
| K200024 |
01/06/2020 |
uMR 570 |
Shanghai United Imaging Healthcare Co., Ltd. |
| K230152 |
01/19/2023 |
uMR Omega |
Shanghai United Imaging Healthcare Co., Ltd. |
| K230162 |
01/20/2023 |
uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis |
Shanghai United Imaging Healthcare Co., Ltd. |
| K240540 |
02/26/2024 |
uMR Omega |
Shanghai United Imaging Healthcare Co., Ltd. |
| K240744 |
03/18/2024 |
uMR 680 |
Shanghai United Imaging Healthcare Co., Ltd. |
| K241079 |
04/19/2024 |
uCT 780 |
Shanghai United Imaging Healthcare Co., Ltd. |
| K191157 |
05/01/2019 |
uMR 780, uMR 790 |
Shanghai United Imaging Healthcare Co., Ltd. |
| K181370 |
05/23/2018 |
uMR 780 |
Shanghai United Imaging Healthcare Co., Ltd. |
| K231482 |
05/23/2023 |
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis |
Shanghai United Imaging Healthcare Co., Ltd. |
| K231572 |
05/31/2023 |
uMI Panorama |
Shanghai United Imaging Healthcare Co., Ltd. |
| K241596 |
06/03/2024 |
uMI Panvivo |
Shanghai United Imaging Healthcare Co., Ltd. |
| K231762 |
06/16/2023 |
uEXPLORER |
Shanghai United Imaging Healthcare Co., Ltd. |
| K222339 |
08/03/2022 |
uDR 380i Pro |
Shanghai United Imaging Healthcare Co., Ltd. |
| K222540 |
08/22/2022 |
uPMR 790 |
Shanghai United Imaging Healthcare Co., Ltd. |
| K192293 |
08/23/2019 |
uDR 592h, uDR 596i |
Shanghai United Imaging Healthcare Co., Ltd. |
| K242624 |
09/03/2024 |
Medical Image Post-processing Software (uOmnispace.CT) |
Shanghai United Imaging Healthcare Co., Ltd. |
| K232712 |
09/05/2023 |
uMI Panorama |
Shanghai United Imaging Healthcare Co., Ltd. |
| K192630 |
09/23/2019 |
uWS-MI |
Shanghai United Imaging Healthcare Co., Ltd. |
| K223028 |
09/29/2022 |
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis |
Shanghai United Imaging Healthcare Co., Ltd. |
| K223325 |
10/31/2022 |
uMI Panorama |
Shanghai United Imaging Healthcare Co., Ltd. |
| K183137 |
11/13/2018 |
uMR 580, uMR 588 |
Shanghai United Imaging Healthcare Co., Ltd. |
| K183164 |
11/15/2018 |
uWS-MR |
Shanghai United Imaging Healthcare Co., Ltd. |
| K183170 |
11/16/2018 |
uWS-CT |
Shanghai United Imaging Healthcare Co., Ltd. |
| K183186 |
11/19/2018 |
Head Coil û 12, Head Coil û 32, Carotid Coil û 8, Temporomandibular Joint Coil û 4, Infant Coil û 24, Cardiac Coil û 24, Foot & Ankle Coil - 24 |
Shanghai United Imaging Healthcare Co., Ltd. |
| K193200 |
11/20/2019 |
uMR Omega |
Shanghai United Imaging Healthcare Co., Ltd. |
| K203448 |
11/23/2020 |
uCT ATLAS with uWS-CT-Dual Energy Analysis |
Shanghai United Imaging Healthcare Co., Ltd. |
| K243632 |
11/25/2024 |
uWS-Angio Basic |
Shanghai United Imaging Healthcare Co., Ltd. |
| K243666 |
11/27/2024 |
uOmniscan |
Shanghai United Imaging Healthcare Co., Ltd. |
| K173953 |
12/27/2017 |
uDR 780i |
Shanghai United Imaging Healthcare Co., Ltd. |
| K234154 |
12/29/2023 |
uPMR 790 |
Shanghai United Imaging Healthcare Co., Ltd. |
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