510(k) K040376

SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE by Sectra-Imtec AB — Product Code LLZ

K040376 is an FDA 510(k) premarket notification submitted by Sectra-Imtec AB for the device "SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE". The FDA issued a decision of Substantially Equivalent on May 4, 2004. 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.