510(k) K891541

MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0. by Diasonics, Inc. — Product Code LNH

K891541 is an FDA 510(k) premarket notification submitted by Diasonics, Inc. for the device "MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0.". The FDA issued a decision of Substantially Equivalent on May 11, 1989. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Diasonics, Inc. has at least 10 other 510(k) clearances on record.