INFX-8000V, INFINIX-CFI AND INFINIX VFI

INFX-8000V, INFINIX-CFI AND INFINIX VFI is an FDA 510(k)-cleared medical device (K081582) 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 16, 2008. Regulation: 8.