RTHawk, HeartVista Workstation with RTHawk

RTHawk, HeartVista Workstation with RTHawk is an FDA 510(k)-cleared medical device (K142997) 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 December 16, 2014. Regulation: 8.