HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE

HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE is an FDA 510(k)-cleared medical device (K933073) manufactured by Heartware Intl. Corp.. 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 6, 1993. Regulation: 8.