SONOLAYER-V, SSA-90A

SONOLAYER-V, SSA-90A is an FDA 510(k)-cleared medical device (K851036) manufactured by Toshiba Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 16, 1985. Regulation: 8.