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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 K073205
Device Name NIO 5MP, MODEL MDNG-5121
Applicant
BARCOVIEW, MEDICAL IMAGING SYSTEMS
35 PRESIDENT KENNEDYPARK
KORTRIJK,  BE B-8500
Applicant Contact NEIL PHILLIPS
Correspondent
BARCOVIEW, MEDICAL IMAGING SYSTEMS
35 PRESIDENT KENNEDYPARK
KORTRIJK,  BE B-8500
Correspondent Contact NEIL PHILLIPS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/13/2007
Decision Date 12/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
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