Shanghai United Imaging Healthcare Co., Ltd.
FDA 510(k) & PMA Approved Devices — 84 products
Total Devices84
Categories10
Latest FDA decision2026-07-28
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K243376 | uAngio AVIVA CX | OWB | 2025-04-28 | View |
| 510(k) | K241166 | uCT 550 | JAK | 2025-01-14 | View |
| 510(k) | K241079 | uCT 780 | JAK | 2025-01-07 | View |
| 510(k) | K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | KPS | 2024-12-12 | View |
| 510(k) | K241068 | uDR 780i | KPR | 2024-11-01 | View |
| 510(k) | K242515 | uDR 380i Pro | IZL | 2024-10-10 | View |
| 510(k) | K241585 | uMI Panorama | KPS | 2024-08-30 | View |
| 510(k) | K241596 | uMI Panvivo | KPS | 2024-08-15 | View |
| 510(k) | K234154 | uPMR 790 | OUO | 2024-05-24 | View |
| 510(k) | K233209 | uOmnispace.CT | QIH | 2024-05-17 | View |
| 510(k) | K233673 | uMR Jupiter | LNH | 2024-04-26 | View |
| 510(k) | K233186 | uOmnispace.MR | QIH | 2024-04-17 | View |
| 510(k) | K240744 | uMR 680 | LNH | 2024-04-10 | View |
| 510(k) | K240540 | uMR Omega | LNH | 2024-03-22 | View |
| 510(k) | K231762 | uEXPLORER | KPS | 2024-01-18 | View |
| 510(k) | K233176 | uOmnispace.MI | LLZ | 2023-12-20 | View |
| 510(k) | K231482 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis | JAK | 2023-11-29 | View |
| 510(k) | K232712 | uMI Panorama | KPS | 2023-10-03 | View |
| 510(k) | K230162 | uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis | JAK | 2023-08-01 | View |
| 510(k) | K231572 | uMI Panorama | KPS | 2023-07-26 | View |
No matching devices.
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