MYLABSEVEN, MYLABALPHA

MYLABSEVEN, MYLABALPHA is an FDA 510(k)-cleared medical device (K142008) manufactured by Esaote, S.p.A.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 11, 2014. Regulation: 8.