510(k) K122451 ยท IYE Accelerator, Linear, Medical
EXACTRAC VERO
| Applicant | Brainlab AG, Feldkirchen, DE |
| Decision | Substantially Equivalent, Sep 28, 2012 |
| Received | Aug 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122451
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2017 | Brainlab AG BRAINLAB EXACTRAC VERO, Model/Catalog Numbers:
46228 EXACTRAC VERO 3.5
46238 EXACTRAC VERO 3.5
46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3
46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4
The ExacTrac Terminated |
IYE | None listed |
| May 4, 2016 | Brainlab AG ExacTrac Vero is a Patient Positioning System for Radiation therapy. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.