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Elekta , Ltd.
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BEAM MODULATOR, MODEL 4513 332 8000 is an FDA 510(k)-cleared medical device (K042794) manufactured by Elekta , 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 January 30, 2005. Regulation: 8.