510(k) K162112

CAAS MRV by Pie Medical Imaging BV — Product Code LLZ

K162112 is an FDA 510(k) premarket notification submitted by Pie Medical Imaging BV for the device "CAAS MRV". The FDA issued a decision of Substantially Equivalent on September 21, 2016. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Pie Medical Imaging BV has at least 10 other 510(k) clearances on record.