dS Small Extremity 16CH 1.5T Coil

dS Small Extremity 16CH 1.5T Coil is an FDA 510(k)-cleared medical device (K162863) manufactured by Invivo Therapeutics 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 November 6, 2016. Regulation: 8.