Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shanghai United Imaging Healthcare Co., Ltd. · Predicate Candidate Screening
84 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
261 days90th percentile
84clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261427 | uMI Panvivo (uMI Panvivo M) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-07-28 | 89 | 0 |
| K260113 | uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. | 2026-05-22 | 128 | 0 |
| K253077 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-22 | 211 | 0 |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-03 | 45 | 0 |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI | Shanghai United Imaging Healthcare Co., Ltd. | 2026-02-13 | 88 | 0 |
| K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2026-01-20 | 116 | 0 |
| K252000 | uDR Arria & uDR Aris | Shanghai United Imaging Healthcare Co., Ltd. | 2025-11-26 | 152 | 0 |
| K252371 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-25 | 57 | 0 |
| K250045 | uWS-Angio Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-24 | 257 | 0 |
| K251167 | uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-19 | 157 | 0 |
| K250040 | uWS-Angio | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-12 | 247 | 0 |
| K250246 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. | 2025-08-05 | 190 | 0 |
| K243547 | uMR Ultra | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 | 244 | 0 |
| K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 | 31 | 0 |
| K243397 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-16 | 258 | 0 |
| K243666 | uOmniscan | Shanghai United Imaging Healthcare Co., Ltd. | 2025-06-17 | 202 | 0 |
| K243122 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-21 | 233 | 0 |
| K243617 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLA | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-16 | 175 | 1 |
| K242624 | Medical Image Post-processing Software (uOmnispace.CT) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-14 | 253 | 0 |
| K243632 | uWS-Angio Basic | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-12 | 168 | 0 |
| K243376 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | 2025-04-28 | 180 | 0 |
| K241166 | uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | 2025-01-14 | 263 | 0 |
| K241079 | uCT 780 | Shanghai United Imaging Healthcare Co., Ltd. | 2025-01-07 | 263 | 1 |
| K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-12-12 | 27 | 0 |
| K241068 | uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. | 2024-11-01 | 196 | 0 |
| K242515 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2024-10-10 | 48 | 0 |
| K241585 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | 2024-08-30 | 88 | 0 |
| K241596 | uMI Panvivo | Shanghai United Imaging Healthcare Co., Ltd. | 2024-08-15 | 73 | 0 |
| K234154 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2024-05-24 | 147 | 0 |
| K233209 | uOmnispace.CT | Shanghai United Imaging Healthcare Co., Ltd. | 2024-05-17 | 232 | 0 |
| K233673 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-26 | 162 | 0 |
| K233186 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-17 | 202 | 0 |
| K240744 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-10 | 23 | 0 |
| K240540 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | 2024-03-22 | 25 | 0 |
| K231762 | uEXPLORER | Shanghai United Imaging Healthcare Co., Ltd. | 2024-01-18 | 216 | 1 |
| K233176 | uOmnispace.MI | Shanghai United Imaging Healthcare Co., Ltd. | 2023-12-20 | 83 | 0 |
| K231482 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLA | Shanghai United Imaging Healthcare Co., Ltd. | 2023-11-29 | 190 | 1 |
| K232712 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | 2023-10-03 | 28 | 1 |
| K230162 | uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-C | Shanghai United Imaging Healthcare Co., Ltd. | 2023-08-01 | 193 | 2 |
| K231572 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | 2023-07-26 | 56 | 0 |
| K230039 | uOmnispace | Shanghai United Imaging Healthcare Co., Ltd. | 2023-07-20 | 195 | 0 |
| K230152 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | 2023-05-23 | 124 | 0 |
| K230758 | uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. | 2023-05-18 | 59 | 0 |
| K223325 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | 2023-03-10 | 130 | 1 |
| K223028 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2023-02-16 | 140 | 0 |
| K222540 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2022-11-14 | 84 | 0 |
| K220332 | uMR Omega with uWS-MR-MRS | Shanghai United Imaging Healthcare Co., Ltd. | 2022-10-27 | 265 | 0 |
| K222339 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2022-09-30 | 58 | 0 |
| K203448 | uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2021-08-11 | 261 | 1 |
| K210001 | HYPER AiR | Shanghai United Imaging Healthcare Co., Ltd. | 2021-04-30 | 116 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda