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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K914728
Device Name KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM
Applicant
EASTMAN KODAK COMPANY
100 CARLSON RD.
ROCHESTER,  NY  14610
Applicant Contact NORMAN H GEIL
Correspondent
EASTMAN KODAK COMPANY
100 CARLSON RD.
ROCHESTER,  NY  14610
Correspondent Contact NORMAN H GEIL
Regulation Number892.2010
Classification Product Code
LMB  
Date Received10/21/1991
Decision Date 03/02/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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