510(k) K212239

XENOVIEW 3.0T Chest Coil by Polarean, Inc. — Product Code MOS

K212239 is an FDA 510(k) premarket notification submitted by Polarean, Inc. for the device "XENOVIEW 3.0T Chest Coil". The FDA issued a decision of Substantially Equivalent on December 23, 2022. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Polarean, Inc. has at least 3 other 510(k) clearances on record.