510(k) K182189 ยท IYE Accelerator, Linear, Medical
Encompass SRS Headframe ; Encompass MR SRS Headframe
| Applicant | Qfix, Avondale PA, US |
| Decision | Substantially Equivalent, Oct 4, 2018 |
| Received | Aug 13, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182189
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.