510(k) K252988 ยท IYE Accelerator, Linear, Medical
ChartCheck (RADCH V1.6)
| Applicant | Radformation, Inc., New York NY, US |
| Decision | Substantially Equivalent, Jan 5, 2026 |
| Received | Sep 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252988
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.