The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Directview Dr 7500 System, Model 8791345.
| Device ID | K051258 |
| 510k Number | K051258 |
| Device Name: | KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 |
| Classification | System, X-ray, Stationary |
| Applicant | EASTMAN KODAK COMPANY 343 STATE STREET Rochester, NY 14650 |
| Contact | Christine E Ehmann |
| Correspondent | Christine E Ehmann EASTMAN KODAK COMPANY 343 STATE STREET Rochester, NY 14650 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-16 |
| Decision Date | 2005-06-01 |