RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK

RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK is an FDA 510(k)-cleared medical device (K133848) 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 24, 2014. Regulation: 8.