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FDA-cleared K243769

QFR (3.0)

QFR Solutions bv

Authorized purpose: QFR (3.0) uses paired coronary X-ray angiographic DICOM acquisitions to calculate three-dimensional vessel and lesion measurements and pressure-drop quantification for interventional cardiologist or researcher review in patients with coronary artery disease.

Modality
Fluoroscopy/Angiography
Anatomy
Heart/Cardiovascular
Decision
2025-04-04