DIGISCOPE RX-2 (9 OPTION)

DIGISCOPE RX-2 (9 OPTION) is an FDA 510(k)-cleared medical device (K965013) manufactured by Medirex, 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 16, 1997. Regulation: 8.