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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 K980118
Device Name KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER
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 Number892.2050
Classification Product Code
LLZ  
Date Received01/13/1998
Decision Date 03/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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