KODAK PACS

System, Image Processing, Radiological

EASTMAN KODAK COMPANY

The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Pacs.

Pre-market Notification Details

Device IDK060055
510k NumberK060055
Device Name:KODAK PACS
ClassificationSystem, Image Processing, Radiological
Applicant EASTMAN KODAK COMPANY 343 STATE STREET Rochester,  NY  14650
ContactCarolyn L Wagner
CorrespondentCarolyn L Wagner
EASTMAN KODAK COMPANY 343 STATE STREET Rochester,  NY  14650
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-09
Decision Date2006-02-07

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