510(k) K183186

Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 by Shanghai United Imaging Healthcare Co., Ltd. — Product Code MOS

K183186 is an FDA 510(k) premarket notification submitted by Shanghai United Imaging Healthcare Co., Ltd. for the device "Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24". The FDA issued a decision of Substantially Equivalent on Feb 8, 2019. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Shanghai United Imaging Healthcare Co., Ltd. has 84 other 510(k) clearances on record.