510(k) K082510

IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0 by Tomtec Imaging Systems GmbH — Product Code LLZ

K082510 is an FDA 510(k) premarket notification submitted by Tomtec Imaging Systems GmbH for the device "IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0". The FDA issued a decision of Substantially Equivalent on October 1, 2008. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Tomtec Imaging Systems GmbH has at least 10 other 510(k) clearances on record.