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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 K960981
Device Name KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY
Applicant
KODAK HEALTH IMAGING SYSTEMS, INC.
18325 WATERVIEW PKWY.
DALLAS,  TX  75252
Applicant Contact STAN E TILLMAN
Correspondent
KODAK HEALTH IMAGING SYSTEMS, INC.
18325 WATERVIEW PKWY.
DALLAS,  TX  75252
Correspondent Contact STAN E TILLMAN
Regulation Number892.2010
Classification Product Code
LMB  
Date Received03/11/1996
Decision Date 06/07/1996
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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