QFR (3.0)
QFR Solutions bvQFR (3.0) is a software device that processes X-ray angiogram images to provide quantitative analysis of coronary vessels. It uses deep learning and 3D reconstruction from angiographic images to measure vessel dimensions and quantify pressure drops, aiding cardiologists in evaluating coronary artery disease and supporting treatment decisions.
Intended Use
QFR is software intended to be used for performing calculations in X-ray angiographic images of the coronary arteries to quantify lesions and pressures.
Technology
QFR uses deep learning models for vessel selection, contour detection, and 3D reconstruction from two angiographic projections taken ≥25º apart. It calculates quantitative flow parameters by combining 3D vessel geometry with patient-specific flow velocity derived from TIMI frame count.
Performance
The device achieved high accuracy in vessel classification (78-96%), start/end point detection (88% correctness), and frame detection (81-83%) in representative datasets. Flow velocity calculation was validated to meet stricter criteria than manual FFR measurements. Users can review and correct AI results before final analysis.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/6/2024
3 months - 2
FDA Approval
4/4/2025
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