The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Carestream Drx-1 System With Drx Core Detectors.
| Device ID | K183474 |
| 510k Number | K183474 |
| Device Name: | Carestream DRX-1 System With DRX Core Detectors |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 |
| Contact | Victoria Wheeler |
| Correspondent | Carolyn L Wagner Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-17 |
| Decision Date | 2019-01-16 |
| Summary: | summary |