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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 K091172
Device Name NIO 2MP (MDNG-2121)
Applicant
Barco N.V.
35 President Kennedypark
8500 Kortrijk,  BE
Applicant Contact LIEVEN DE WANDEL
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/22/2009
Decision Date 05/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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