PRE-LOADED GOLD VISICOIL CK MARKER

PRE-LOADED GOLD VISICOIL CK MARKER is an FDA 510(k)-cleared medical device (K120859) manufactured by Radiomed Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 18, 2012. Regulation: 8.