The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Drx-revolution Mobile X-ray System.
| Device ID | K120062 |
| 510k Number | K120062 |
| Device Name: | DRX-REVOLUTION MOBILE X-RAY SYSTEM |
| Classification | System, X-ray, Mobile |
| Applicant | CARESTREAM HEALTH, INC. 12921 W Washington Blvd Los Angeles, CA 90066 |
| Contact | Carolyn Wagner |
| Correspondent | Carolyn Wagner CARESTREAM HEALTH, INC. 12921 W Washington Blvd Los Angeles, CA 90066 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-09 |
| Decision Date | 2012-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889978612499 | K120062 | 000 |
| 60889978007257 | K120062 | 000 |
| 60889971060174 | K120062 | 000 |
| 60889971019400 | K120062 | 000 |
| 60889971019394 | K120062 | 000 |
| 60889971002631 | K120062 | 000 |