Ultrasound system, imaging, application program software

Intended purpose

This software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. The software is an accessory to compatible general purpose diagnostic ultrasound systems. The software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients. The EF feature is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation.