ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)

ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) is an FDA 510(k)-cleared medical device (K250652) manufactured by Anumana, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 27, 2025. Regulation: 8.