XENOVIEW 3.0T Chest Coil

XENOVIEW 3.0T Chest Coil is an FDA 510(k)-cleared medical device (K212239) manufactured by Polarean, 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 December 22, 2022. Regulation: 8.