510(k) K230854 ยท LLZ System, Image Processing, Radiological
SwiftMR
| Applicant | Airs Medical, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Oct 27, 2023 |
| Received | Mar 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230854
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.