510(k) K152321 ยท IYE Accelerator, Linear, Medical
kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View wi
| Applicant | Qfix, Avondale PA, US |
| Decision | Substantially Equivalent, Dec 4, 2015 |
| Received | Aug 17, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152321
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.