MODIFICATION OF ACUSON V510B TRANSDUCER

MODIFICATION OF ACUSON V510B TRANSDUCER is an FDA 510(k)-cleared medical device (K933663) manufactured by Acuson Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 20, 1994. Regulation: 8.