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Elekta Oncology Systems, Ltd.
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ELEKTA SYNERGY SYSTEM is an FDA 510(k)-cleared medical device (K032996) manufactured by Elekta Oncology Systems, Ltd.. 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 22, 2003. Regulation: 8.