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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 K140828
FOIA Releasable 510(k) K140828
Device Name NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE
Applicant
Brainreader Aps
Skagenvej 21
Egaa,  DK 8250
Applicant Contact METTE MUNCH
Correspondent
Brainreader Aps
Skagenvej 21
Egaa,  DK 8250
Correspondent Contact METTE MUNCH
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
LNH  
Date Received04/01/2014
Decision Date 02/04/2015
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
Recalls CDRH Recalls
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