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Philips Medical Systems North America Co.
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PHILIPS EASYDIAGNOST ELEVA is an FDA 510(k)-cleared medical device (K031535) 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 June 16, 2003. Regulation: 8.