SONICATH(TM) 3.5 F, 20 MHZ

SONICATH(TM) 3.5 F, 20 MHZ is an FDA 510(k)-cleared medical device (K913890) 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 November 8, 1992. Regulation: 8.