510(k) K003473 ยท IZH System, X-Ray, Mammographic
DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM
| Applicant | Elscintec Systems , Ltd., Haifa, IL |
| Decision | Substantially Equivalent, Nov 28, 2000 |
| Received | Nov 8, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003473
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.