510(k) K961983

TRS 2000 TELERADIOLOGY SYSTEM by Sectra-Imtec AB — Product Code LLZ

K961983 is an FDA 510(k) premarket notification submitted by Sectra-Imtec AB for the device "TRS 2000 TELERADIOLOGY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 13, 1996. 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.