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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 K040365
Device Name COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
Applicant
Barco N.V.
12200 Academy Rd. NE, # 931
Albuquerque,  NM  87111
Applicant Contact FRANK FERGUSON
Correspondent
Barco N.V.
12200 Academy Rd. NE, # 931
Albuquerque,  NM  87111
Correspondent Contact FRANK FERGUSON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/13/2004
Decision Date 04/28/2004
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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