510(k) K942561 ยท IXK System, Imaging, X-Ray, Electrostatic
FUJI FCR IMAGE PROCESSING UNIT IP-U515
| Applicant | Fujifilm Medical System U.S.A., Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Dec 23, 1994 |
| Received | May 31, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942561
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.