510(k) K934478 ยท IZH System, X-Ray, Mammographic
ALPHA STEREO
| Applicant | Instrumentarium Corp., Tuusula, Finland, FI |
| Decision | Substantially Equivalent, Jan 31, 1995 |
| Received | Sep 14, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934478
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.