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Accutome, Inc.
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ACCUSONIC A-SCAN MODEL, 24-4000 is an FDA 510(k)-cleared medical device (K032956) manufactured by Accutome, Inc.. 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 9, 2003. Regulation: 8.