HEARTNAVIGATOR RELEASE 1

HEARTNAVIGATOR RELEASE 1 is an FDA 510(k)-cleared medical device (K111245) 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 July 28, 2011. Regulation: 8.