510(k) K201378 ยท OAS X-Ray, Tomography, Computed, Dental
3D Accuitomo 150N
| Applicant | J. Morita USA, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 18, 2021 |
| Received | May 26, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201378
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.