510(k) K252179

GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only by Shenzhen RF Tech Co., Ltd. — Product Code MOS

K252179 is an FDA 510(k) premarket notification submitted by Shenzhen RF Tech Co., Ltd. for the device "GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only". The FDA issued a decision of Substantially Equivalent on February 10, 2026. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Shenzhen RF Tech Co., Ltd. has at least 10 other 510(k) clearances on record.