QLAB Advanced Quantification Software

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

No function tag matched Derived by keyword rules; see methodology

Problem the AI is intended to solve

The Philips QLAB Advanced Quantification Software System (QLAB) is designed to view and quantify image data acquired on Philips ultrasound systems. QLAB is available either as a stand-alone product that can function on a standard PC, a dedicated workstation, and on-board Philips' ultrasound systems. https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200974.pdf

Expected benefits

Supports ultrasound workflows.

System outputs

Recommends measurements of areas of interest.

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.

Potential impacts and how they were identified

Not reported