510(k) K253738

3.0T AIR 32CH HNA by Ge Healthcare Coils (Usa Instruments, Inc.) — Product Code MOS

K253738 is an FDA 510(k) premarket notification submitted by Ge Healthcare Coils (Usa Instruments, Inc.) for the device "3.0T AIR 32CH HNA". The FDA issued a decision of Substantially Equivalent on January 23, 2026. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Ge Healthcare Coils (Usa Instruments, Inc.) has at least 10 other 510(k) clearances on record.