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The Cardiac Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. Cardiac Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. The Cardiac Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV). Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).

The Cardiac Guidance software is a radiological computer-assisted acquisition guidance system that provides real-time guidance during echocardiography to assist the user capture anatomically correct images representing standard 2D echocardiographic diagnostic views and orientations. This Al-powered, software-only device emulates the expertise of skilled sonographers. Cardiac Guidance is comprised of several different features that, combined, provide expert guidance to the user. These include: - Quality Meter: The real-time feedback from the Quality Meter advises the user on the expected diagnostic quality of the resulting clip, such that the user can make decisions to further optimize the quality, for example by following the prescriptive guidance feature below. - Prescriptive Guidance: The prescriptive guidance feature in Cardiac Guidance provides direction to the user to emulate how a sonographer would manipulate the transducer to acquire the optimal view. - Auto-Capture: The Cardiac Guidance Auto-Capture feature triggers an automatic capture of a clip when the quality is predicted to be diagnostic, emulating the way in which a sonographer knows when an image is of sufficient quality to be diagnostic and records it. - Save Best Clip: This feature continually assesses clip quality while the user is scanning and, in the event that the user is not able to obtain a clip sufficient for Auto-Capture, the software allows the user to retrospectively record the highest quality clip obtained so far, mimicking the choice a sonographer might make when recording an exam.