RTHawk, HeartVista Cardiac Package

RTHawk, HeartVista Cardiac Package is an FDA 510(k)-cleared medical device (K153740) manufactured by Heartvista, 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 June 29, 2016. Regulation: 8.