S-SCAN, MODEL 9800020010

S-SCAN, MODEL 9800020010 is an FDA 510(k)-cleared medical device (K100670) 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 April 4, 2010. Regulation: 8.