510(k) K994283

MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM by Medis Medical Imaging Systems BV — Product Code LNH

K994283 is an FDA 510(k) premarket notification submitted by Medis Medical Imaging Systems BV for the device "MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM". The FDA issued a decision of Substantially Equivalent on August 30, 2000. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Medis Medical Imaging Systems BV has at least 10 other 510(k) clearances on record.