510(k) K253564 ยท KPS System, Tomography, Computed, Emission
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Feb 13, 2026 |
| Received | Nov 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253564
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.