RADIONICS VARILINK 2

RADIONICS VARILINK 2 is an FDA 510(k)-cleared medical device (K023519) manufactured by Radionics, A Division of Tyco Healthcare Group LP. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 15, 2003. Regulation: 8.