The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Drx-evolution With Carestream Digital Tomosynthesis.
| Device ID | K191879 |
| 510k Number | K191879 |
| Device Name: | DRX-Evolution With Carestream Digital Tomosynthesis |
| Classification | System, X-ray, Stationary |
| Applicant | Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 |
| Contact | Duane Gutowski |
| Correspondent | Duane Gutowski Carestream Health, Inc. 150 Verona Street 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 | 2019-07-15 |
| Decision Date | 2019-12-20 |