510(k) K190524

MRopen 0.5 T by Asg Superconductors S.P.A. — Product Code LNH

K190524 is an FDA 510(k) premarket notification submitted by Asg Superconductors S.P.A. for the device "MRopen 0.5 T". The FDA issued a decision of Substantially Equivalent on July 1, 2019. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Asg Superconductors S.P.A. has at least 3 other 510(k) clearances on record.