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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 K181939
Device Name icobrain
Applicant
Icometrix NV
Kolonel Begaultlaan 1b/12
Leuven,  BE 3012
Applicant Contact Jan Verheyden
Correspondent
Icometrix NV
Kolonel Begaultlaan 1b/12
Leuven,  BE 3012
Correspondent Contact Jan Verheyden
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/19/2018
Decision Date 11/06/2018
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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