The following data is part of a premarket notification filed by Carestream Health with the FDA for Drx-rise Mobile X-ray System.
| Device ID | K213568 |
| 510k Number | K213568 |
| Device Name: | DRX-Rise Mobile X-ray System |
| Classification | System, X-ray, Mobile |
| Applicant | Carestream Health 150 Verona St Rochester, NY 14608 |
| Contact | Gina Maiolo |
| Correspondent | Gina Maiolo Carestream Health 150 Verona St 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 | 2021-11-09 |
| Decision Date | 2022-03-23 |