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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 K192962
Device Name icobrain-ctp
Icometrix NV
Kolonel Begaultlaan 1b/12
leuven,  BE 3012
Applicant Contact dirk smeets
Icometrix NV
Kolonel Begaultlaan 1b/12
leuven,  BE 3012
Correspondent Contact dirk smeets
Regulation Number892.2050
Classification Product Code
Date Received10/22/2019
Decision Date 02/28/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No