ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)

ARRAY OPEN BREAST COIL (MODEL OBC-63 PA) is an FDA 510(k)-cleared medical device (K961525) manufactured by Mri Devices Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 4, 1996. Regulation: 8.