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Visage Breast Density

Key Features

  • Breast density classification

General Information

Product name

Visage Breast Density

Subspeciality

Breast

Modality

Mammography

Disease targeted

Breast cancer

Main task

Not specified

Technical Specifications

Population

Intended for symptomatic and asymptomatic female adults

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, Etc., Image upload, On demand, Right after the image acquisition, Triggered by a user through e.g. a button click

Processing time

< 3 sec

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

Market Presence

On market since

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

AI Platforms

Not specified

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

Evidence & Research

Peer-Reviewed Papers

Peer-Reviewed

View

PACS-integrated machine learning breast density classifier: clinical validation

Source: vendor | First published: Jul 19, 2023 | Last updated: Jul 9, 2025