VA · VA-24-1069 · record R2236

AGFA DR 800 with MUSICA Dynamic

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: Image and video analysis, Clinical and medical Derived by keyword rules; see methodology

Problem the AI is intended to solve

It can accelerate X-ray workflows. The optional image processing allows users to conveniently select image processing settings for different patient sizes and examinations. The image processing algorithms in the new device are similar to those previously cleared and used in Agfa’s radiography portfolio today which includes the DR 600 (K152639) and DR 400 (K141192). The addition of the dynamic image processing is identical to the predicate device (K140380).

Expected benefits

Accelerate X-Ray workflows.

System outputs

Recommendations for image processing settings.

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