510(k) K190320 ยท OAS X-Ray, Tomography, Computed, Dental
PreXion3D Explorer
| Applicant | Prexion Corporation, Chiyoda-Ku, JP |
| Decision | Substantially Equivalent, Apr 15, 2019 |
| Received | Feb 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190320
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.