The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak X-omatic Ident. Camera Mammography Upgrade.
| Device ID | K920031 |
| 510k Number | K920031 |
| Device Name: | KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE |
| Classification | System, X-ray, Film Marking, Radiographic |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Contact | Milagros Montes |
| Correspondent | Milagros Montes EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Product Code | JAC |
| CFR Regulation Number | 892.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-03 |
| Decision Date | 1992-02-12 |