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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 K163013
Device Name Quantib Brain 1.2
Quantib BV
Westblaak 106
Rotterdam,  NL 3012KM
Applicant Contact Rudolf Scholte
Quantib BV
Westblaak 106
Rotterdam,  NL 3012KM
Correspondent Contact Rudolf Scholte
Regulation Number892.2050
Classification Product Code
Date Received10/28/2016
Decision Date 01/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No