TLC PEDIATRIC FRAME, MODEL TLC-SYS

TLC PEDIATRIC FRAME, MODEL TLC-SYS is an FDA 510(k)-cleared medical device (K991523) manufactured by Radionics, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 29, 1999. Regulation: 8.