510(k) K071232

IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS by Tomtec Imaging Systems GmbH — Product Code LLZ

K071232 is an FDA 510(k) premarket notification submitted by Tomtec Imaging Systems GmbH for the device "IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS". The FDA issued a decision of Substantially Equivalent on June 20, 2007. 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.