FDA 510(k) Application Details - K201411

Device Classification Name	More FDA Info for this Device
510(K) Number	K201411
Device Name	Visage Breast Density
Applicant	Visage Imaging GmbH Lepsiusstrasse 70 Berlin 12163 DE Other 510(k) Applications for this Company
Contact	Stefan Strowich Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2020
Decision Date	01/29/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review