The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Carestream Pacs.
| Device ID | K053347 |
| 510k Number | K053347 |
| Device Name: | KODAK CARESTREAM PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Contact | Carolyn L Wagner |
| Correspondent | Carolyn L Wagner EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-02 |
| Decision Date | 2006-01-04 |