The following data is part of a premarket notification filed by Carestream Health,inc. with the FDA for Drx-evolution.
| Device ID | K141837 |
| 510k Number | K141837 |
| Device Name: | DRX-EVOLUTION |
| Classification | System, X-ray, Stationary |
| Applicant | CARESTREAM HEALTH,INC. 150 VERONA ST Rochester, NY 14608 |
| Contact | Carolyn L Wagner |
| Correspondent | Carolyn L Wagner CARESTREAM HEALTH,INC. 150 VERONA ST Rochester, NY 14608 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-07 |
| Decision Date | 2015-03-11 |
| Summary: | summary |