XRE COLLIMATOR WITH SPECTRAL FILTER

XRE COLLIMATOR WITH SPECTRAL FILTER is an FDA 510(k)-cleared medical device (K984414) manufactured by Trex Medical Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 29, 1998. Regulation: 8.