510(k) K983313 ยท IZH System, X-Ray, Mammographic
ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
| Applicant | Elscint, Inc., Rockleigh NJ, US |
| Decision | Substantially Equivalent, Dec 11, 1998 |
| Received | Sep 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983313
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.