PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0

PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0 is an FDA 510(k)-cleared medical device (K022899) manufactured by Philips Medical Systems North America Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 21, 2002. Regulation: 8.