CINE'VIEW - STRESS ECHO & IMAGE REVIEW

CINE'VIEW - STRESS ECHO & IMAGE REVIEW is an FDA 510(k)-cleared medical device (K904976) manufactured by Prism Imaging, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 24, 1991. Regulation: 8.