510(k) K231762 ยท KPS System, Tomography, Computed, Emission
uEXPLORER
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Jan 18, 2024 |
| Received | Jun 16, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231762
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2025 | UIH Technologies LLC Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System
Model:uEXPLORER
MD, Rx Only Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.