Public source

Reviewed 7 Jun 2026

Completeness Good (44%)

The QVCAD System is indicated for use as an aid to the radiologist during breast screening procedures for women who have negative mammograms but have had a 3D breast ultrasound (ABUS") because of her dense breast tissue. The QVCAD CAD engine employs several image pattern recognition processes and artificial neural networks to detect suspicious areas in the breast. The objective is to distinguish potential breast lesions from normal breast tissue.

Supported by 3 papers

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Key Features

  • Breast abnormality detection
  • Region analysis

General Information

Product name

QVCAD

Modality

Ultrasound

Main task

Not specified

Subspeciality

Breast

Disease targeted

Breast cancer

Regulatory Information

CE Certification

Pathway:

MDR

Class:

Class unknown

Not verified by Health AI Register

FDA Certification

Pathway:

PMA approved

Class:

Class III

FDA Number:

PMA P150043

View FDA record

Verified by Health AI Register

Other certifications

Not specified

Technical Specifications

Patient population age

Not specified

Input

3D breast ultrasound

Input format

DICOM

Output

Not specified

Output format

Not specified

Integration

Not specified

Deployment

Not specified

Trigger for analysis

Not specified

Processing time

Not specified

Population

Not specified

Market Presence

On market since

09-2016

AI Platforms

Resellers

Not specified

Countries present

Not specified

Paying clinical customers

Not specified

Research/test users

Not specified

Pricing Information

Pricing model

Not specified

Based on

Not specified

Source: Public | First published: Jan 23, 2023 | Last updated: Jun 7, 2026