KODAK INSIGHT PORTABLE IMAGING SYSTEM

Cassette, Radiographic Film

EASTMAN KODAK COMPANY

The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Insight Portable Imaging System.

Pre-market Notification Details

Device IDK921826
510k NumberK921826
Device Name:KODAK INSIGHT PORTABLE IMAGING SYSTEM
ClassificationCassette, Radiographic Film
Applicant EASTMAN KODAK COMPANY 343 STATE ST. Rochester,  NY  14650
ContactNorman H Geil
CorrespondentNorman H Geil
EASTMAN KODAK COMPANY 343 STATE ST. Rochester,  NY  14650
Product CodeIXA  
CFR Regulation Number892.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-16
Decision Date1992-08-26

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