510(k) K120062 ยท IZL System, X-Ray, Mobile
DRX-REVOLUTION MOBILE X-RAY SYSTEM
| Applicant | Carestream Health, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Apr 13, 2012 |
| Received | Jan 9, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120062
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2017 | Carestream Health Inc DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution ---
The DRX-Revolution is a mobile sy Terminated |
IZL | None listed |
| Jan 12, 2017 | Carestream Health Inc Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 146 Terminated |
IZL | None listed |
| Dec 16, 2014 | Carestream Health Inc DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc.
The DRX-Revolution Mobile X-Ray Syst Terminated |
IZL | None listed |
| Nov 7, 2013 | Carestream Health Inc. DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608
to perform radiographic x-ray examinations on all pediatri Terminated |
IZL | None listed |
| Nov 1, 2013 | Carestream Health Inc. DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only).
The device is designed to perform radiographic x-ray examinations on Terminated |
IZL | None listed |
| Oct 31, 2013 | Carestream Health, Inc. Carestream DRX-Revolution Mobile X-ray System.
Produces radiographic images. Terminated |
IZL | None listed |
| Oct 31, 2013 | Carestream Health, Inc. DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608
Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150
The device is designed t Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.