HEARTNAVIGATOR RELEASE 2.0

HEARTNAVIGATOR RELEASE 2.0 is an FDA 510(k)-cleared medical device (K140138) manufactured by Philips Medical Systems Nederland B.V.. 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 9, 2014. Regulation: 8.