The following data is part of a premarket notification filed by Carestream Health with the FDA for Lux 35 Detector.
| Device ID | K203159 |
| 510k Number | K203159 |
| Device Name: | Lux 35 Detector |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| 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 | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-23 |
| Decision Date | 2020-12-02 |