510(k) K921962 ยท IZH System, X-Ray, Mammographic
LORAD DIGITAL SPOT MAMMOGRAPHY
| Applicant | Lorad Medical Systems, Inc., Danbury CT, US |
| Decision | Substantially Equivalent, Nov 23, 1992 |
| Received | Apr 27, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921962
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.