510(k) K973631 ยท IZH System, X-Ray, Mammographic
LORAD M-III ELITE (M-III E)
| Applicant | Lorad Corp., Danbury CT, US |
| Decision | Substantially Equivalent, Dec 23, 1997 |
| Received | Sep 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973631
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.