ACUSON I5100 ULTRASOUND TRANSDUCER

ACUSON I5100 ULTRASOUND TRANSDUCER is an FDA 510(k)-cleared medical device (K884632) 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 12, 1989. Regulation: 8.