CARDIAC TRIAD NUCLEAR IMAGING SYSTEM

CARDIAC TRIAD NUCLEAR IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K920776) 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 April 26, 1992. Regulation: 8.