L-LINEX-RAY FLUORESCENCE

L-LINEX-RAY FLUORESCENCE is an FDA 510(k)-cleared medical device (K911749) manufactured by Montifore Medical Center. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 19, 1991. Regulation: 8.