THERAPAX DXT 300 SERIES 3

THERAPAX DXT 300 SERIES 3 is an FDA 510(k)-cleared medical device (K923584) manufactured by Oldelft Corp. of America. 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 14, 1993. Regulation: 8.