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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 K192130
Device Name Icobrain
Applicant
Icometrix NV
Kolonel Begaultlaan 1b/12
leuven,  BE 3012
Applicant Contact dirk smeets
Correspondent
Icometrix NV
Kolonel Begaultlaan 1b/12
leuven,  BE 3012
Correspondent Contact dirk smeets
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/07/2019
Decision Date 12/13/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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