| 2026-05-22 | K260113 | uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2026-04-22 | K253077 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2026-04-03 | K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2026-02-13 | K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2026-01-20 | K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2025-09-25 | K252371 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2025-09-19 | K251167 | uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2025-08-05 | K250246 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2025-07-17 | K243547 | uMR Ultra | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2025-07-17 | K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2025-07-16 | K243397 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2025-05-21 | K243122 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2025-05-16 | K243617 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology |
| 2025-05-14 | K242624 | Medical Image Post-processing Software (uOmnispace.CT) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2025-04-28 | K243376 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology |
| 2025-01-14 | K241166 | uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2025-01-07 | K241079 | uCT 780 | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2024-12-12 | K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology |
| 2024-08-30 | K241585 | uMI Panorama | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology |
| 2024-08-15 | K241596 | uMI Panvivo | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2024-05-24 | K234154 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2024-05-17 | K233209 | uOmnispace.CT | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2024-04-26 | K233673 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd | Radiology |
| 2024-04-17 | K233186 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2024-04-10 | K240744 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2024-03-22 | K240540 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2023-12-20 | K233176 | uOmnispace.MI | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2023-10-03 | K232712 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2023-07-26 | K231572 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2023-07-20 | K230039 | uOmnispace | Shanghai United Imaging Healthcare Co., Ltd | Radiology |
| 2023-03-10 | K223325 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2023-02-16 | K223028 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2022-10-27 | K220332 | uMR Omega with uWS-MR-MRS | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology |
| 2021-08-11 | K203448 | uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2021-04-30 | K210001 | HYPER AiR | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology |
| 2020-08-04 | K193210 | HYPER DLR | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2020-07-06 | K193073 | Deep Recon | Shanghai United Imaging Healthcare Co., Ltd. | Radiology |
| 2020-06-01 | K192601 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd | Radiology |
| 2020-05-05 | K193176 | uMR 780 | Shanghai United Imaging Healthcare Co., Ltd | Radiology |