510(k) K201101

1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil by Neocoil, LLC — Product Code MOS

K201101 is an FDA 510(k) premarket notification submitted by Neocoil, LLC for the device "1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil". The FDA issued a decision of Substantially Equivalent on June 2, 2020. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Neocoil, LLC has at least 10 other 510(k) clearances on record.