
Amicas, Inc.
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AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0 is an FDA 510(k)-cleared medical device (K022970) manufactured by Amicas, 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 November 21, 2002. Regulation: 8.