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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 K972380
Device Name KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)
Applicant
Eastman Kodak Company
18325 Waterview Pkwy.
Dallas,  TX  75252
Applicant Contact NANCY BUTCHER
Correspondent
Eastman Kodak Company
18325 Waterview Pkwy.
Dallas,  TX  75252
Correspondent Contact NANCY BUTCHER
Regulation Number892.2010
Classification Product Code
LMB  
Date Received06/26/1997
Decision Date 09/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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