510(k) K161973

G-scan Brio, S-scan by Esaote, S.p.A. — Product Code LNH

K161973 is an FDA 510(k) premarket notification submitted by Esaote, S.p.A. for the device "G-scan Brio, S-scan". The FDA issued a decision of Substantially Equivalent on October 25, 2016. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Esaote, S.p.A. has at least 10 other 510(k) clearances on record.