MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX

MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX is an FDA 510(k)-cleared medical device (K013985) manufactured by Machnet BV. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 31, 2002. Regulation: 8.