Shanghai United Imaging Healthcare Co., Ltd.
29 AI-enabled device listings under this company name on the FDA list. The name is copied as published. It is not a review of the company.
| Date | Submission | Device | Panel | Code |
|---|---|---|---|---|
| May 22, 2026 | K260113 | uMR Astra | Radiology | LNH |
| April 22, 2026 | K253077 | uOmnispace.MR | Radiology | QIH |
| April 3, 2026 | 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) | Radiology | KPS |
| February 13, 2026 | K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Radiology | KPS |
| January 20, 2026 | K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | Radiology | JAK |
| September 25, 2025 | K252371 | uMR 680 | Radiology | LNH |
| September 19, 2025 | K251167 | uDR Aurora CX | Radiology | KPR |
| August 5, 2025 | K250246 | uMR Jupiter | Radiology | LNH |
| July 17, 2025 | K243547 | uMR Ultra | Radiology | LNH |
| July 17, 2025 | K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Radiology | KPS |
| July 16, 2025 | K243397 | uMR 680 | Radiology | LNH |
| May 21, 2025 | K243122 | uMR Omega | Radiology | LNH |
| May 14, 2025 | K242624 | Medical Image Post-processing Software (uOmnispace.CT) | Radiology | QIH |
| January 14, 2025 | K241166 | uCT 550 | Radiology | JAK |
| January 7, 2025 | K241079 | uCT 780 | Radiology | JAK |
| August 15, 2024 | K241596 | uMI Panvivo | Radiology | KPS |
| May 24, 2024 | K234154 | uPMR 790 | Radiology | OUO |
| May 17, 2024 | K233209 | uOmnispace.CT | Radiology | QIH |
| April 17, 2024 | K233186 | uOmnispace.MR | Radiology | QIH |
| April 10, 2024 | K240744 | uMR 680 | Radiology | LNH |
| March 22, 2024 | K240540 | uMR Omega | Radiology | LNH |
| December 20, 2023 | K233176 | uOmnispace.MI | Radiology | LLZ |
| October 3, 2023 | K232712 | uMI Panorama | Radiology | KPS |
| July 26, 2023 | K231572 | uMI Panorama | Radiology | KPS |
| March 10, 2023 | K223325 | uMI Panorama | Radiology | KPS |
| February 16, 2023 | K223028 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis | Radiology | JAK |
| August 11, 2021 | K203448 | uCT ATLAS with uWS-CT-Dual Energy Analysis | Radiology | JAK |
| August 4, 2020 | K193210 | HYPER DLR | Radiology | KPS |
| July 6, 2020 | K193073 | Deep Recon | Radiology | JAK |