510(k) K970680 ยท IZH System, X-Ray, Mammographic
GLORY
| Applicant | Elscint, Inc., Hackensack NJ, US |
| Decision | Substantially Equivalent, Jun 20, 1997 |
| Received | Feb 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970680
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.