The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Insight Portable Imaging System.
Device ID | K921826 |
510k Number | K921826 |
Device Name: | KODAK INSIGHT PORTABLE IMAGING SYSTEM |
Classification | Cassette, Radiographic Film |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Norman H Geil |
Correspondent | Norman H Geil EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | IXA |
CFR Regulation Number | 892.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-16 |
Decision Date | 1992-08-26 |