510(k) K203173 ยท IYE Accelerator, Linear, Medical
ExacTrac Dynamic
| Applicant | Brainlab AG, Munich, DE |
| Decision | Substantially Equivalent, Nov 12, 2020 |
| Received | Oct 26, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203173
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2021 | Brainlab AG ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a m Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.