QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM

QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM is an FDA 510(k)-cleared medical device (K892711) manufactured by Quantitative Cardiac Systems (Qcs), 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 December 13, 1989. Regulation: 8.