510(k) K941353 ยท IZH System, X-Ray, Mammographic
MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM
| Applicant | Elscint, Inc., Hackensack NJ, US |
| Decision | Substantially Equivalent, Mar 31, 1995 |
| Received | Mar 21, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941353
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.