510(k) K011582

QCU ANALYTICAL SOFTWARE PACKAGE by Medis Medical Imaging Systems BV — Product Code LLZ

K011582 is an FDA 510(k) premarket notification submitted by Medis Medical Imaging Systems BV for the device "QCU ANALYTICAL SOFTWARE PACKAGE". The FDA issued a decision of Substantially Equivalent on July 31, 2001. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Medis Medical Imaging Systems BV has at least 10 other 510(k) clearances on record.