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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automated radiological image processing software
510(k) Number K201411
Device Name Visage Breast Density
Applicant
Visage Imaging GmbH
Lepsiusstrasse 70
berlin,  DE 12163
Applicant Contact stefan strowich
Correspondent
QiP GmbH
Struveweg 40
ludwigsfelde,  DE 14974
Correspondent Contact juliane dinter
Regulation Number892.2050
Classification Product Code
QIH  
Date Received05/28/2020
Decision Date 01/29/2021
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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