OMB Individually Reported
QLAB Advanced Quantification Software
High riskExact public inventory row
Description
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
Detailed example
Recommends measurements of areas of interest.
AI / analytics pattern
Computer Vision: AI that processes and interprets visual data (e.g., images and videos).
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
Supports ultrasound workflows.
Controls / human review
ATO: Not reported; PIA: Not published