510(k) K162085 ยท OAS X-Ray, Tomography, Computed, Dental
i-CAT FLX V series / KaVo 3D eXam+ V series
| Applicant | Imaging Sciences International, Hatfield PA, US |
| Decision | Substantially Equivalent, Nov 10, 2016 |
| Received | Jul 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162085
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.