510(k) K160458 ยท EHD Unit, X-Ray, Extraoral With Timer
BI IMAGE-X EVOLUTION
| Applicant | Radiotecnologia Industrial S.A. DE C.V., Ixtapaluca, MX |
| Decision | Substantially Equivalent, Jun 20, 2016 |
| Received | Feb 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160458
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.