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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Diagnostic Radiology
510(k) Number K143157
Device Name Coronis Fusion 4MP LED
Applicant
BARCO NV
35 PRESIDENT KENNEDYPARK
KORTRIJK,  BE
Applicant Contact LIEVEN DE WANDEL
Correspondent
BARCO NV
35 PRESIDENT KENNEDYPARK
KORTRIJK,  BE
Correspondent Contact LIEVEN DE WANDEL
Regulation Number892.2050
Classification Product Code
PGY  
Date Received11/03/2014
Decision Date 11/12/2014
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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