510(k) K253012 ยท IYE Accelerator, Linear, Medical
AlignRT Plus (8.0)
| Applicant | Vision Rt, Ltd., London, GB |
| Decision | Substantially Equivalent, Mar 18, 2026 |
| Received | Sep 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253012
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.