510(k) K251839 ยท KPS System, Tomography, Computed, Emission
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Jul 17, 2025 |
| Received | Jun 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251839
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software Open, Classified |
KPS | None listed |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software Open, Classified |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.