SONOLAYER ALPHA, MODEL SSH-140A

SONOLAYER ALPHA, MODEL SSH-140A is an FDA 510(k)-cleared medical device (K913798) manufactured by Toshiba America Medical Systems, In.C. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 31, 1992. Regulation: 8.