510(k) K131448

3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION by Koelis — Product Code LLZ

K131448 is an FDA 510(k) premarket notification submitted by Koelis for the device "3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION". The FDA issued a decision of Substantially Equivalent on Jul 26, 2013. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Koelis has 6 other 510(k) clearances on record.