DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T

DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T is an FDA 510(k)-cleared medical device (K122646) manufactured by Invivo 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 1, 2012. Regulation: 8.