ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES

ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES is an FDA 510(k)-cleared medical device (K052078) 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 September 6, 2005. Regulation: 8.