510(k) K211939 ยท IYE Accelerator, Linear, Medical
ExacTrac Dynamic
| Applicant | Brainlab AG, Munich, DE |
| Decision | Substantially Equivalent, Jul 22, 2021 |
| Received | Jun 23, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211939
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2022 | Brainlab AG ExacTrac Dynamic software model numbers:
20910-01, ETD Positioning and Moni. 1.0.0 INST;
20910-01A, ETD Positioning and Moni. 1.0.1 INST;
20910-01B, ETD Positioning and Moni. 1.0.2 INST; and
20910-0 Open, Classified |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.