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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 K031132
Device Name CONSULTIVA CASE INPUT STATION, MODEL CIS-1
Applicant
EASTMAN KODAK COMPANY
100 CENTURY CENTER COURT SUITE
600
SAN JOSE,  CA  95112
Applicant Contact WIDO MENHARDT
Correspondent
EASTMAN KODAK COMPANY
100 CENTURY CENTER COURT SUITE
600
SAN JOSE,  CA  95112
Correspondent Contact WIDO MENHARDT
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/09/2003
Decision Date 11/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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