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 | K191025 |
| 510k Number | K191025 |
| Device Name: | DRX-Revolution Mobile X-ray System |
| Classification | System, X-ray, Mobile |
| Applicant | Carestream Health Inc. 150 Verona Street Rochester, NY 14608 |
| Contact | Gina Maiolo |
| Correspondent | Gina Maiolo Carestream Health Inc. 150 Verona Street Rochester, NY 14608 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-18 |
| Decision Date | 2019-05-17 |
| Summary: | summary |