510(k) K081469

SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2 by Sectra Imtec AB — Product Code LLZ

K081469 is an FDA 510(k) premarket notification submitted by Sectra Imtec AB for the device "SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2". The FDA issued a decision of Substantially Equivalent on June 12, 2008. 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.