510(k) K051258 ยท KPR System, X-Ray, Stationary
KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345
| Applicant | Eastman Kodak Company, Rochester NY, US |
| Decision | Substantially Equivalent, Jun 1, 2005 |
| Received | May 16, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051258
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2014 | Carestream Health, Inc. Kodak DirectView DR 7500 Diagnostic X-Ray System
Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head t Terminated |
KPR | None listed |
| Jan 27, 2014 | Carestream Health, Inc. KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A. Terminated |
KPR | None listed |
| Jan 21, 2014 | Carestream Health, Inc. DR 7500 with FF WS
These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimat Terminated |
IZL | None listed |
| Jun 30, 2007 | Carestream Health, Inc. Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary X-Ray System. Device Listing # E222512. Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.