510(k) K081093

3-D IMAGING WORKSTATION by Eigen, LLC — Product Code LLZ

K081093 is an FDA 510(k) premarket notification submitted by Eigen, LLC for the device "3-D IMAGING WORKSTATION". The FDA issued a decision of Substantially Equivalent on May 1, 2008. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Eigen, LLC has at least 10 other 510(k) clearances on record.