DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582V

DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582V is an FDA 510(k)-cleared medical device (K891453) manufactured by Toshiba Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 31, 1989. Regulation: 8.