510(k) K120975 ยท MUH System, X-Ray, Extraoral Source, Digital
CS 8100 CS 8100 ACCESS
| Applicant | Trophy, Marne La Vallee Cedex 2, FR |
| Decision | Substantially Equivalent, Jun 22, 2012 |
| Received | Apr 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120975
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2015 | Carestream Health, Inc. CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110
Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals Terminated |
MUH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.