LBS-63-16 BREAST ARRAY COIL

LBS-63-16 BREAST ARRAY COIL is an FDA 510(k)-cleared medical device (K072873) manufactured by Invivo. 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 15, 2007. Regulation: 8.