510(k) K260947

0.55T 12Ch Breast Coil by Neocoil, LLC — Product Code MOS

K260947 is an FDA 510(k) premarket notification submitted by Neocoil, LLC for the device "0.55T 12Ch Breast Coil". The FDA issued a decision of Substantially Equivalent on April 23, 2026. 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.