Visage Breast Density

Automated Radiological Image Processing Software

Visage Imaging GmbH

The following data is part of a premarket notification filed by Visage Imaging Gmbh with the FDA for Visage Breast Density.

Pre-market Notification Details

Device IDK201411
510k NumberK201411
Device Name:Visage Breast Density
ClassificationAutomated Radiological Image Processing Software
Applicant Visage Imaging GmbH Lepsiusstrasse 70 Berlin,  DE 12163
ContactStefan Strowich
CorrespondentJuliane Dinter
QiP GmbH Struveweg 40 Ludwigsfelde,  DE 14974
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-28
Decision Date2021-01-29

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