3.0T AIR 32CH HNA

3.0T AIR 32CH HNA is an FDA 510(k)-cleared medical device (K253738) 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 22, 2026. Regulation: 8.