510(k) K944046 ยท IXW Processor, Radiographic-Film, Automatic
FUJI COMPUTED RADIOGRAPHY SYSTEMS
| Applicant | Fujifilm Medical System U.S.A., Inc., Stamford CT, US |
| Decision | Substantially Equivalent, May 11, 1995 |
| Received | Aug 18, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944046
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2016 | Fujifilm Medical Systems U.S.A., Inc. Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU Terminated |
IXW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.