510(k) K922619 ยท IZH System, X-Ray, Mammographic
DIGITIZER, MODEL # 3-000A-1518
| Applicant | Lorad Medical Systems, Inc., Danbury CT, US |
| Decision | Substantially Equivalent, Jul 1, 1992 |
| Received | May 29, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922619
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.