510(k) K020635 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976
| Applicant | Eastman Kodak Company, Rochester NY, US |
| Decision | Substantially Equivalent, Mar 21, 2002 |
| Received | Feb 27, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K020635
| 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.