3.0T 16ch Breast Coil

3.0T 16ch Breast Coil is an FDA 510(k)-cleared medical device (K173377) manufactured by Neocoil, LLC. 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 27, 2017. Regulation: 8.