CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM

CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM is an FDA 510(k)-cleared medical device (K973630) manufactured by Siemens Medical Solutions USA, 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 December 4, 1997. Regulation: 8.