THERMATREK IRIS-IV INFRARED IMAGING SYSTEM

THERMATREK IRIS-IV INFRARED IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K030165) manufactured by Thermatrek. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 15, 2003. Regulation: 8.