SonoSite gets 510(k) clearance for SonoHeart

January 12, 2000

SonoSite gained 510(k) clearance from the Food and Drug Administration to market its SonoHeart hand-held echocardiography system. SonoHeart weighs only 5.4 pounds and delivers digital echocardiography with 2-D and color Doppler images on demand,

SonoSite gained 510(k) clearance from the Food and Drug Administration to market its SonoHeart hand-held echocardiography system. SonoHeart weighs only 5.4 pounds and delivers digital echocardiography with 2-D and color Doppler images on demand, according to the Bothell, WA-based company. It is designed to enable physicians to conduct faster and more accurate cardiac evaluations, including assessing and documenting left ventricular function, chamber size, the source of murmurs, wall thickness, valve regurgitation, and cardiomyopathies. The company expects to begin taking orders and shipping systems this quarter.