510(k) K923554 ยท IXW Processor, Radiographic-Film, Automatic
KODAK EKTASCAN
| Applicant | Eastman Kodak Company, Rochester NY, US |
| Decision | Substantially Equivalent, Feb 12, 1993 |
| Received | Jul 17, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923554
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2014 | Carestream Health, Inc. CARESTREAM DIRECTVIEW CR Software
Generates digital mammographic images that can be used for screening and diagnosis of breast cancer. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.