510(k) K161881 ยท OAS X-Ray, Tomography, Computed, Dental
PreXion3D Excelsior
| Applicant | Prexion Corporation, Chiyoda-Ku, JP |
| Decision | Substantially Equivalent, Oct 3, 2016 |
| Received | Jul 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161881
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.