The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Directview Dr 3000 System 64kw/80kw Generators, Models 6551345, 6551386.
| Device ID | K060550 |
| 510k Number | K060550 |
| Device Name: | KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 |
| Classification | System, X-ray, Stationary |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
| Contact | Christine E Ehmann |
| Correspondent | Christine E Ehmann EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-02 |
| Decision Date | 2006-03-31 |
| Summary: | summary |