SSA-390A/POWER VISION 8000

SSA-390A/POWER VISION 8000 is an FDA 510(k)-cleared medical device (K991858) 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 June 15, 1999. Regulation: 8.