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Infraredx, Inc.
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TVC IMAGING SYSTEM MODEL NIRS-MC7-70 is an FDA 510(k)-cleared medical device (K123108) 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 March 14, 2013. Regulation: 8.