MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS

MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS is an FDA 510(k)-cleared medical device (K892397) manufactured by Nuccardiac Software, 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 October 26, 1989. Regulation: 8.