510(k) K251483 ยท QIH Automated Radiological Image Processing Software
SwiftSight-Brain
| Applicant | Airs Medical, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Sep 23, 2025 |
| Received | May 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251483
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.