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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 K960382
Device Name KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER
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 Number892.2020
Classification Product Code
LMD  
Date Received01/25/1996
Decision Date 04/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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