The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Carestream Dryview 5850 Laser Imager.
| Device ID | K090469 |
| 510k Number | K090469 |
| Device Name: | CARESTREAM DRYVIEW 5850 LASER IMAGER |
| Classification | Camera, Multi Format, Radiological |
| Applicant | CARESTREAM HEALTH, INC. 1 IMATION WAY 304-4B-28 Oakdale, MN 55128 -3414 |
| Contact | Gayle Carroll |
| Correspondent | Gayle Carroll CARESTREAM HEALTH, INC. 1 IMATION WAY 304-4B-28 Oakdale, MN 55128 -3414 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-23 |
| Decision Date | 2009-05-22 |
| Summary: | summary |