OPTION PHO/SONIC B-MODE SCANNER

OPTION PHO/SONIC B-MODE SCANNER is an FDA 510(k)-cleared medical device (K781344) manufactured by G.D. Searle and 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 August 20, 1978. Regulation: 8.