510(k) K063846

EIGEN DSA 2000 by Eigen — Product Code LLZ

K063846 is an FDA 510(k) premarket notification submitted by Eigen for the device "EIGEN DSA 2000". The FDA issued a decision of Substantially Equivalent on January 26, 2007. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Eigen has at least 10 other 510(k) clearances on record.