510(k) K033712

MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 by Sectra-Imtec AB — Product Code LLZ

K033712 is an FDA 510(k) premarket notification submitted by Sectra-Imtec AB for the device "MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1". The FDA issued a decision of Substantially Equivalent on December 23, 2003. 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 8 other 510(k) clearances on record.