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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K053347
Device Name KODAK CARESTREAM PACS
Applicant
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Applicant Contact CAROLYN L WAGNER
Correspondent
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Correspondent Contact CAROLYN L WAGNER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/02/2005
Decision Date 01/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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