510(k) K220338 ยท IYE Accelerator, Linear, Medical
ExacTrac Dynamic
| Applicant | Brainlab AG, Munich, DE |
| Decision | Substantially Equivalent, Apr 29, 2022 |
| Received | Feb 7, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220338
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2023 | Brainlab AG Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F. Open, Classified |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.