510(k) K250170 ยท KPS System, Tomography, Computed, Emission
PHAROS
| Applicant | Brightonix Imaging, Seoul, KR |
| Decision | Substantially Equivalent, Aug 15, 2025 |
| Received | Jan 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250170
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.