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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K974107
Device Name KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW)
Applicant
Eastman Kodak Company
18325 Waterview Pkwy.
Dallas,  TX  75252 -8026
Applicant Contact NANCY BUTCHER
Correspondent
Eastman Kodak Company
18325 Waterview Pkwy.
Dallas,  TX  75252 -8026
Correspondent Contact NANCY BUTCHER
Regulation Number892.2020
Classification Product Code
LMD  
Date Received10/31/1997
Decision Date 01/21/1998
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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