510(k) K254010 ยท IYE Accelerator, Linear, Medical
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
| Applicant | Brainlab SE, Munich, DE |
| Decision | Substantially Equivalent, Jan 14, 2026 |
| Received | Dec 15, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K254010
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.