510(k) K162145

vRad PACS with Mammography by Virtual Radiologic Corporation — Product Code LLZ

K162145 is an FDA 510(k) premarket notification submitted by Virtual Radiologic Corporation for the device "vRad PACS with Mammography". The FDA issued a decision of Substantially Equivalent on October 25, 2016. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Virtual Radiologic Corporation has at least 2 other 510(k) clearances on record.