CARDIAC TRIAD NEW DETECTOR OPTION

CARDIAC TRIAD NEW DETECTOR OPTION is an FDA 510(k)-cleared medical device (K923151) manufactured by Trionix Research Laboratory, 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 September 9, 1992. Regulation: 8.