510(k) K260792 ยท IYE Accelerator, Linear, Medical
AerFrame Patient Immobilization System (AFPIS)
| Applicant | Stabilix, LLC, Dallas TX, US |
| Decision | Substantially Equivalent, May 8, 2026 |
| Received | Mar 11, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260792
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.