510(k) K051315

MODIFICATION TO: SECTRA IDS5 WORKSTATION by Sectra Imtec AB — Product Code LLZ

K051315 is an FDA 510(k) premarket notification submitted by Sectra Imtec AB for the device "MODIFICATION TO: SECTRA IDS5 WORKSTATION". The FDA issued a decision of Substantially Equivalent on June 15, 2005. 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.