INFX-8000F (INFINIX CSI AND INFINIX DPI)

INFX-8000F (INFINIX CSI AND INFINIX DPI) is an FDA 510(k)-cleared medical device (K081624) 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 22, 2008. Regulation: 8.