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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 K013922
Device Name CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM
Applicant
BARCO NV
P.O. BOX 12038
la jolla,  CA  92039 -2038
Applicant Contact frank ferguson
Correspondent
BARCO NV
P.O. BOX 12038
la jolla,  CA  92039 -2038
Correspondent Contact frank ferguson
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/27/2001
Decision Date 01/28/2002
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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