510(k) K103342

3.0T METAFLEXCOIL by Neocoil, LLC — Product Code MOS

K103342 is an FDA 510(k) premarket notification submitted by Neocoil, LLC for the device "3.0T METAFLEXCOIL". The FDA issued a decision of Substantially Equivalent on December 23, 2010. 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.