The SpectraWAVE X1-FFR Software is a standalone medical device which is used in the catheterization lab as an angiography image assessment tool for assessingFractional Flow Reserve using non-invasive quantitative and functional analysis of coronary vasculature.The SpectraWAVE X1-FFR software comprises image processing and computational algorithms to perform functional coronary angiography, providing longitudinal estimations of coronary pressure drop and Fractional Flow Reserve (FFR) during angiogram and percutaneous coronary intervention (PCI) procedures. The SpectraWAVE X1-FFR Software is a procedural aid intended to be used to support diagnosis by clinicians.AI-derived algorithms are deployed on the device to support vessel segmentation and contouring. Analytical (non-AI) models are used for generating FFR values.The SpectraWAVE X1-FFR Software • provides measurements of localized coronary pressure drops over the length of a coronary vessel, including the right and left coronary tree.• provides dimensions of the coronary vessels and the amount of stenosis in coronary vessels; • enables physiology assessment in a non-invasive manner, without the need for adenosine and without the need for additional radiation and contrast administration.
A freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system.