8 CHANNEL CARDIAC PHASED ARRAY COIL

8 CHANNEL CARDIAC PHASED ARRAY COIL is an FDA 510(k)-cleared medical device (K101492) manufactured by Ge Healthcare Coils (Usa Instruments, 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 June 22, 2010. Regulation: 8.