
Infraredx, Inc.
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INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 is an FDA 510(k)-cleared medical device (K072932) manufactured by Infraredx, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 24, 2008. Regulation: 8.