FLEXART V3.5 SOFTWARE

FLEXART V3.5 SOFTWARE is an FDA 510(k)-cleared medical device (K970573) manufactured by Toshiba America Mri, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 20, 1997. Regulation: 8.