510(k) K244054

16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) by Quality Electrodynamics — Product Code MOS

K244054 is an FDA 510(k) premarket notification submitted by Quality Electrodynamics for the device "16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)". The FDA issued a decision of Substantially Equivalent on February 28, 2025. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Quality Electrodynamics has at least 10 other 510(k) clearances on record.