FLEXART,FLEXART/HYPER, VISART, VISART/HYPER

FLEXART,FLEXART/HYPER, VISART, VISART/HYPER is an FDA 510(k)-cleared medical device (K983110) 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 February 24, 1999. Regulation: 8.