510(k) K132544

TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA by Tomtec Imaging Systems GmbH — Product Code LLZ

K132544 is an FDA 510(k) premarket notification submitted by Tomtec Imaging Systems GmbH for the device "TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA". The FDA issued a decision of Substantially Equivalent on November 25, 2013. 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.