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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 K012155
Device Name KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
Applicant
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650 -1131
Applicant Contact ANNE ZAVERTNIK
Correspondent
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650 -1131
Correspondent Contact ANNE ZAVERTNIK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/11/2001
Decision Date 08/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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