510(k) K243142 ยท IYE Accelerator, Linear, Medical
Cranial 4Pi Immobilization
| Applicant | Brainlab AG, Munich, DE |
| Decision | Substantially Equivalent, Jun 23, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243142
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.