UltraSight AI Guidance
Ultrasight, Inc.
Ultrasight, Inc.
PMN#
GUDID#
UltraSight Guidance - V1
2026-05-25
PVAD IQ - The PVAD IQ software is intended for non-invasive analysis of ultrasound images to detect and measure structures fromcardiac ultrasound of patients 18 years old and above, with a Percutaneous Ventricular Assist Device (PVAD). Such use istypically utilized for clinical decision support by a qualified physician.
2026-05-13
UltraSight Guidance - The UltraSight Guidance is intended to assist medical professionals (not including expert sonographers) in acquiring cardiac ultrasound images. UltraSight Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems. UltraSight Guidance 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).
2026-04-20