510(k) K111861

SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE by Siemens Medical Systems USA — Product Code LLZ

K111861 is an FDA 510(k) premarket notification submitted by Siemens Medical Systems USA for the device "SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE". The FDA issued a decision of Substantially Equivalent on Jan 6, 2012. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Siemens Medical Systems USA has 2 other 510(k) clearances on record.