QFR is software intended to be used for performing calculations in X-ray angiographic images of the coronary arteries. QFR enables interventional cardiologists and researchers to obtain quantifications of one or more lesions in the analyzed coronary vessel segment. In particular, QFR provides:• Quantitative results of coronary vessel segments based on a 3D reconstructed model;• Dimensions of the cardiovascular vessels and lesions;• Quantification of the pressure drop in coronary vesselsQFR is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease. When the quantified results provided by QFR are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.
An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).