510(k) K141837 ยท KPR System, X-Ray, Stationary
DRX-EVOLUTION
| Applicant | Carestream Health, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Mar 11, 2015 |
| Received | Jul 7, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141837
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2015 | Carestream Health Inc CARESTREAM DRX-EVOLUTION X-Ray System
Product Usage:
The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.