The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Drx-revolution Nano Mobile X-ray System.
| Device ID | K170755 |
| 510k Number | K170755 |
| Device Name: | DRX-Revolution Nano Mobile X-ray System |
| Classification | System, X-ray, Mobile |
| Applicant | Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 |
| Contact | Victoria Wheeler |
| Correspondent | Victoria Wheeler Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-13 |
| Decision Date | 2017-06-21 |
| Summary: | summary |