PHILIPS GYROSCAN INTERA (*)

PHILIPS GYROSCAN INTERA (*) is an FDA 510(k)-cleared medical device (K992533) 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 October 17, 1999. Regulation: 8.