SONICATH(TM) 9F, 12 MHZ

SONICATH(TM) 9F, 12 MHZ is an FDA 510(k)-cleared medical device (K902245) manufactured by Boston Scientific 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 October 8, 1990. Regulation: 8.