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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 K142196
Device Name Visage Ease Pro
Applicant
VISAGE IMAGING GMBH
LEPSIUSTRASSE 70
BERLIN,  DE 12163
Applicant Contact Stefan Strowich
Correspondent
VISAGE IMAGING GMBH
LEPSIUSTRASSE 70
BERLIN,  DE 12163
Correspondent Contact Stefan Strowich
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/11/2014
Decision Date 04/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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