510(k) K944816 ยท IZH System, X-Ray, Mammographic
SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Feb 8, 1995 |
| Received | Sep 29, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944816
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.