510(k) K912963

INSTRUMENTARIUM MEGA4 by Instrumentarium Imaging, Inc. — Product Code LNH

K912963 is an FDA 510(k) premarket notification submitted by Instrumentarium Imaging, Inc. for the device "INSTRUMENTARIUM MEGA4". The FDA issued a decision of Substantially Equivalent on September 30, 1991. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Instrumentarium Imaging, Inc. has at least 10 other 510(k) clearances on record.