3.5 MHZ BIOPSY TRANSDUCER

3.5 MHZ BIOPSY TRANSDUCER is an FDA 510(k)-cleared medical device (K812929) manufactured by General Electric Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 23, 1981. Regulation: 8.