510(k) K090318 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
CARESTREAM DRX-1 SYSTEM
| Applicant | Carestream Health, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Apr 6, 2009 |
| Received | Feb 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090318
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2013 | Carestream Health Inc. CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608
to perform radiographic x-ray examinations on all pediat Terminated |
MQB | None listed |
| Aug 13, 2012 | Carestream Health, Inc. Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device o Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.