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Philips Medical Systems
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ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 is an FDA 510(k)-cleared medical device (K063559) manufactured by Philips Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 3, 2007. Regulation: 8.