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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 K153653
Device Name DICOM Viewer
Applicant
Brainlab AG
Kapellenstr. 12
feldkirchen,  DE 85622
Applicant Contact rainer birkenbach
Correspondent
Brainlab AG
Kapellenstr. 12
feldkirchen,  DE 85622
Correspondent Contact alexander schwiersch
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/21/2015
Decision Date 04/13/2016
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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