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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
Predetermined Change
Control Plan Authorized		 No
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