TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE

TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE is an FDA 510(k)-cleared medical device (K982157) manufactured by Field Effects. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 1, 1998. Regulation: 8.