The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Carestream Drx-1 System.
| Device ID | K150766 |
| 510k Number | K150766 |
| Device Name: | Carestream DRX-1 System |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 |
| Contact | Carolyn L Wagner |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-24 |
| Decision Date | 2015-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889978607587 | K150766 | 000 |
| 60889974160192 | K150766 | 000 |
| 60889974160185 | K150766 | 000 |
| 60889974008470 | K150766 | 000 |
| 60889974008463 | K150766 | 000 |
| 60889974000238 | K150766 | 000 |
| 60889974000221 | K150766 | 000 |
| 60889975950549 | K150766 | 000 |
| 60889975950532 | K150766 | 000 |