DIAGNOSTIC ULTRASOUND SYSTEM: MODEL SSA-250A

DIAGNOSTIC ULTRASOUND SYSTEM: MODEL SSA-250A is an FDA 510(k)-cleared medical device (K892386) 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 September 11, 1989. Regulation: 8.