510(k) K031590

SECTRA ORTHOPEDIC PACKAGE by Sectra-Imtec AB — Product Code LLZ

K031590 is an FDA 510(k) premarket notification submitted by Sectra-Imtec AB for the device "SECTRA ORTHOPEDIC PACKAGE". The FDA issued a decision of Substantially Equivalent on October 2, 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.