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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 K153351
Device Name Quantib Brain 1
Applicant
QUANTIB BV
WESTBLAAK 106
ROTTERDAM,  NL NL-3012 KM
Applicant Contact FLOOR VAN LEEUWEN
Correspondent
QUANTIB BV
WESTBLAAK 106
ROTTERDAM,  NL NL-3012 KM
Correspondent Contact FLOOR VAN LEEUWEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/20/2015
Decision Date 06/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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