510(k) K253486 ยท LLZ System, Image Processing, Radiological
SKIA-Head (Model: SKIA-ST00)
| Applicant | Skia, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Feb 23, 2026 |
| Received | Oct 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253486
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.