510(k) K034059

SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE by Sectra AB — Product Code LLZ

K034059 is an FDA 510(k) premarket notification submitted by Sectra AB for the device "SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE". The FDA issued a decision of Substantially Equivalent on March 9, 2004. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Sectra AB has at least 4 other 510(k) clearances on record.