510(k) K172143 ยท KPS System, Tomography, Computed, Emission
uMI 780 PET/CT System
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Apr 13, 2018 |
| Received | Jul 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172143
| 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 780 Open, Classified |
KPS | None listed |
| Oct 21, 2025 | UIH Technologies LLC Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System
Model:uMI 780
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.