510(k) K060550 ยท KPR System, X-Ray, Stationary
KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386
| Applicant | Eastman Kodak Company, Rochester NY, US |
| Decision | Substantially Equivalent, Mar 31, 2006 |
| Received | Mar 2, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060550
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2020 | Carestream Health, Inc. Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Consol Terminated |
KPR | None listed |
| Feb 23, 2008 | Carestream Health, Inc. Kodak DirectView Model DR 3000 System, Stationary X-ray System; Catalog #s 6551360, 6551386, 6552152, 6552160, 6551345, 6552319, 6552335. The units are labeled under the following firms: EASTMAN KODAK Terminated |
KPR | None listed |
| Jul 3, 2007 | Carestream Health, Inc. Kodak Direct View DR3000 System, Stationary X-ray System, Catalog #s 655-1345, 655-1386. Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.