SONOLAYER - V, SSA-100A.

SONOLAYER - V, SSA-100A. is an FDA 510(k)-cleared medical device (K863269) 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 July 21, 1987. Regulation: 8.