510(k) K151137 ยท OAS X-Ray, Tomography, Computed, Dental
X-VIEW, IMAGEN
| Applicant | Edlen Imaging, LLC, Scottsdale AZ, US |
| Decision | Substantially Equivalent, Jun 7, 2016 |
| Received | Apr 29, 2015 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K151137
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.