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ProductsVisage Breast Density

Vendor source

Reviewed 11 May 2026

Completeness Strong (67%)

Visage Breast Density

Visage Imaging, Inc.

Only available with Visage 7 Enterprise Imaging Platform and Hologic equipment
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 Enterprise Imaging Platform for distributing, viewing, processing, and archiving medical images. AI inference is calculated automatically upon study ingest into PACS so that results are available upon study open.

Supported by 1 paper

Visage Breast Density

Key Features

  • Breast density classification

General Information

Product name

Visage Breast Density

Modality

Mammography

Main task

Not specified

Subspeciality

Breast

Disease targeted

Breast cancer

Regulatory Information

CE Certification

Pathway:

MDD

Class:

Class IIa

Verified by Health AI Register

FDA Certification

Pathway:

510(k) cleared

Class:

Class II

Verified by Health AI Register

Other certifications

Not specified

Evidence & Research

Technical Specifications

Patient population age

Not specified

Input

Full Field Digital Mammograms or C-View images (i.e. synthetic mammograms created from tomosynthesis data sets) from Hologic.

Input format

DICOM

Output

Breast density classification (adjustable by radiologist), confidence score. Integration with reporting software via Visage 7 possible.

Output format

Not specified

Integration

Integration in standard reading environment (PACS)

Deployment

Cloud-based, Locally virtualized (virtual machine, Docker)

Trigger for analysis

Automatically, right after the image acquisition, On demand, triggered by a user through e.g. a button click, image upload

Processing time

< 10 seconds

Population

Intended for symptomatic and asymptomatic female adults

Market Presence

On market since

EU: 05/2020, USA: 01/ 2021, CAN: 07/2020, AUS: 07/2020

AI Platforms

Resellers

Not specified

Countries present

4 countries / areas (EU)

Paying clinical customers

Not specified

Research/test users

2

Pricing Information

Pricing model

Not specified

Based on

Not specified

Source: Vendor | First published: Jul 19, 2023 | Last updated: May 11, 2026