510(k) K063093

SECTRA WORKSTATION, VERSION 11.1 by Sectra Imtec AB — Product Code LLZ

K063093 is an FDA 510(k) premarket notification submitted by Sectra Imtec AB for the device "SECTRA WORKSTATION, VERSION 11.1". The FDA issued a decision of Substantially Equivalent on November 7, 2006. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Sectra Imtec AB has at least 4 other 510(k) clearances on record.