510(k) K133406 ยท OAS X-Ray, Tomography, Computed, Dental
CS 8100 3D
| Applicant | Trophy, Marne La Vallee Cedex 2, FR |
| Decision | Substantially Equivalent, Mar 14, 2014 |
| Received | Nov 6, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133406
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2015 | Carestream Health, Inc. CS 8100 3D, CATALOG # (s): 5311162, 5311188.
Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial Terminated |
MUH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.