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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 K062621
Device Name NIO 5MP-21 AND MDNG-5121 CB
Applicant
Barcoview
35 President Kennedypark
Kortrijk,  BE B-8500
Applicant Contact LIEVEN DE WANDEL
Correspondent
Barcoview
35 President Kennedypark
Kortrijk,  BE B-8500
Correspondent Contact LIEVEN DE WANDEL
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/05/2006
Decision Date 03/19/2007
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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