
Ge Healthcare Coils (Usa Instruments, Inc.)
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DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A is an FDA 510(k)-cleared medical device (K103365) 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 January 11, 2011. Regulation: 8.