510(k) K213766

dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T by Invivo Corporation — Product Code MOS

K213766 is an FDA 510(k) premarket notification submitted by Invivo Corporation for the device "dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T". The FDA issued a decision of Substantially Equivalent on December 23, 2021. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Invivo Corporation has at least 10 other 510(k) clearances on record.