510(k) K091889 ยท KPR System, X-Ray, Stationary
DRX-EVOLUTION, MODEL VX3733-SYS
| Applicant | Carestream Health, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jul 20, 2009 |
| Received | Jun 24, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091889
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2014 | Carestream Health, Inc. DRX-Evolution 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 co Terminated |
IZL | None listed |
| Jan 21, 2014 | Carestream Health, Inc. DRX-Evolution with CSH 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 c Terminated |
IZL | None listed |
| Aug 12, 2013 | Carestream Health Inc. Carestream DRX Evolution System, X-Ray System ---
The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.