CEQUAL(TM) QUANITATIVE ANALYSIS CARDIOLITE(R) SPEC

CEQUAL(TM) QUANITATIVE ANALYSIS CARDIOLITE(R) SPEC is an FDA 510(k)-cleared medical device (K914296) 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 November 26, 1991. Regulation: 8.