CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS

CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS is an FDA 510(k)-cleared medical device (K071534) manufactured by Confirma, 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 July 8, 2007. Regulation: 8.