510(k) K213731 ยท KPS System, Tomography, Computed, Emission
EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
| Applicant | Ever Fortune.Ai, Co., Ltd., Taichung City, TW |
| Decision | Substantially Equivalent, May 31, 2022 |
| Received | Nov 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213731
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.