The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Dryview 8610 Laser Imager / For Mammography.
| Device ID | K002146 |
| 510k Number | K002146 |
| Device Name: | KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY |
| Classification | Camera, Multi Format, Radiological |
| Applicant | EASTMAN KODAK COMPANY 1 IMATION PL. 304-4B-75 Oakdale, MN 55128 -3414 |
| Contact | Stephen G Slavens |
| Correspondent | Stephen G Slavens EASTMAN KODAK COMPANY 1 IMATION PL. 304-4B-75 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 | 2000-07-17 |
| Decision Date | 2000-09-27 |