# K201411: Visage Breast Density

- Pathway: 510(k) (Traditional)
- Applicant: Visage Imaging GmbH
- Decided: Jan 29, 2021 after 246 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K904519 (1991). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180125: PowerLook Density Assessment Software, Icad, Inc. (2018) Summary page 4.

## Indications for use
Visage Breast Density is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Visage Breast Density assesses breast density from a mammography study and provides an ACR BI-RADS Atlas 5th Edition breast density category to aid radiologists in the assessment of breast tissue composition. Visage Breast Density produces adjunctive information. It is not a diagnostic aid. Visage Breast Density is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images.

Source page: https://510kreport.com/device/K201411
Methodology: https://510kreport.com/methodology