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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
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 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
Predetermined Change
Control Plan Authorized		 No
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