3.0T 16ch AIR AA

3.0T 16ch AIR AA is an FDA 510(k)-cleared medical device (K223378) 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 2, 2023. Regulation: 8.