
Infraredx, Inc.
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INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 is an FDA 510(k)-cleared medical device (K052908) 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 June 22, 2006. Regulation: 8.