EchoMD Automated Ejection Fraction Software

EchoMD Automated Ejection Fraction Software is an FDA 510(k)-cleared medical device (K173780) manufactured by Bay Labs, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 13, 2018. Regulation: 8.