The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Pacs.
Device ID | K060055 |
510k Number | K060055 |
Device Name: | KODAK PACS |
Classification | System, Image Processing, Radiological |
Applicant | EASTMAN KODAK COMPANY 343 STATE STREET Rochester, NY 14650 |
Contact | Carolyn L Wagner |
Correspondent | Carolyn L Wagner EASTMAN KODAK COMPANY 343 STATE STREET Rochester, NY 14650 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-09 |
Decision Date | 2006-02-07 |