SONOLAYER-L, SAL-77B

SONOLAYER-L, SAL-77B is an FDA 510(k)-cleared medical device (K863947) 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 January 8, 1987. Regulation: 8.