510(k) K201276 ยท IYE Accelerator, Linear, Medical
ExacTrac Dynamic
| Applicant | Brainlab AG, Munich, DE |
| Decision | Substantially Equivalent, Jul 13, 2020 |
| Received | May 13, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201276
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2021 | Brainlab AG ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.