OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON

OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON is an FDA 510(k)-cleared medical device (K993574) 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 January 17, 2000. Regulation: 8.