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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 K981053
Device Name KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW
Applicant
EASTMAN KODAK COMPANY
18325 WATERVIEW PKWY.
DALLAS,  TX  75252 -8026
Applicant Contact ROBERT WOLFARTH
Correspondent
EASTMAN KODAK COMPANY
18325 WATERVIEW PKWY.
DALLAS,  TX  75252 -8026
Correspondent Contact ROBERT WOLFARTH
Regulation Number892.2020
Classification Product Code
LMD  
Date Received03/23/1998
Decision Date 06/18/1998
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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