The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Eclipse Image Processing Software.
Device ID | K060137 |
510k Number | K060137 |
Device Name: | KODAK ECLIPSE IMAGE PROCESSING SOFTWARE |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Linda Stewart |
Correspondent | Linda Stewart EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-19 |
Decision Date | 2006-03-16 |