510(k) K210001 ยท KPS System, Tomography, Computed, Emission
HYPER AiR
| Applicant | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Apr 30, 2021 |
| Received | Jan 4, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210001
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.