SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER

SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER is an FDA 510(k)-cleared medical device (K120796) manufactured by Superdimension, 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 October 25, 2012. Regulation: 8.