PHILIPS GYROVIEW HR - RELEASE 2

PHILIPS GYROVIEW HR - RELEASE 2 is an FDA 510(k)-cleared medical device (K923944) manufactured by Philips Medical Systems North America, 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 April 26, 1993. Regulation: 8.