CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM

CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM is an FDA 510(k)-cleared medical device (K964265) 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 November 11, 1996. Regulation: 8.