OMB Individually Reported

FFRangio

High riskExact public inventory row

Description

FFRangio analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided as a supportive aid for qualified clinicians in the evaluation and assessment of the physiology of coronary arteries.

Detailed example

FFRangio uses standard angiographic images that are retrieved from the X-ray Imaging System (C-arm) in Digital Imaging and Communications in Medicine (DICOM) format. The user selects the images and, following the system prompts, marks key features on the images, including the target lesion, ostium location, main vessel, target vessel, and its side branches. The system then matches the corresponding vessels among the projections and generates a 3D computer model of the vessels. The 3D model is used for blood flow analysis and determination of the FFRangio.

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

Support coronary artery analysis.

Controls / human review

ATO: Not reported; PIA: Not published