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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 K161148
Device Name icobrain
Tervuuresteenweg 224
Leuven,  BE 3001
Applicant Contact Dirk Loeckx
Tervuuresteenweg 224
Leuven,  BE 3001
Correspondent Contact Dirk Loeckx
Regulation Number892.2050
Classification Product Code
Date Received04/22/2016
Decision Date 08/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No