510(k) K994282

MRI- FLOW ANALYTICAL SOFTWARE PACKAGE by Medis Medical Imaging Systems BV — Product Code LNH

K994282 is an FDA 510(k) premarket notification submitted by Medis Medical Imaging Systems BV for the device "MRI- FLOW ANALYTICAL SOFTWARE PACKAGE". The FDA issued a decision of Substantially Equivalent on March 2, 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.