VA · VA-24-3951 · record R2258

Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

Department of Veterans Affairs · VHA: Veterans Health Administration

Overview

Development stage: DeployedSource: c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
High-impact designation: High-impactSource: a) High-impact
Impact justification: Not reported
Start date: Not reported
Withheld from public reporting: Not reported

Mission

Topic area: Health and Medical
Operational functions: Clinical and medical Derived by keyword rules; see methodology

Problem the AI is intended to solve

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes. https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.

Expected benefits

Accelerate ultrasound workflows.

System outputs

Recommended image contours.

Technology

AI classification: Computer visionSource: Computer Vision: AI that processes and interprets visual data (e.g., images and videos).
System name(s): Not reported
Custom-developed code: No
Public source code: Not reported

Sourcing

How it was built: Purchased from vendorSource: a) Purchased from a vendor
Vendor (as reported): Not reported
Vendors (standardized): None on the standard list

A vendor is the supplier named by the agency. It does not identify the underlying model or AI technology.

Data and privacy

Involves PII: Not reported
Privacy Impact Assessment: Not reported
Authorization to Operate: Not reported
Demographic features: Not reported
Training and evaluation data: Not reported
Federal Data Catalog: Not reported

Governance

0 of 8 minimum-practice questions answered. A blank answer means the agency reported nothing; it does not mean the practice is absent.

Pre-deployment testingNo answer reported

AI impact assessmentNo answer reported

Independent reviewNo answer reported

Ongoing monitoringNo answer reported

Operator trainingNo answer reported

Fail-safeNo answer reported

Appeal processNo answer reported

User and public consultationNo answer reported

Potential impacts and how they were identified

Not reported