510(k) K974597 ยท KPR System, X-Ray, Stationary
ADC COMPACT (AGFA DIAGNOSTIC CENTER)
| Applicant | Bayer Corp., Agfa Div., Ridgefield Park NJ, US |
| Decision | Substantially Equivalent, Mar 9, 1998 |
| Received | Dec 9, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974597
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2006 | AGFA Corp. ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa''s computed radiography product line. Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.