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Calypso Medical Technologies, Inc.
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CALYPSO SYSTEM WITH DYNAMIC EDGE GATING is an FDA 510(k)-cleared medical device (K102373) manufactured by Calypso Medical Technologies, 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 September 29, 2010. Regulation: 8.