510(k) K182561

UroNav (Version 3.0) by Invivo Corporation — Product Code LLZ

K182561 is an FDA 510(k) premarket notification submitted by Invivo Corporation for the device "UroNav (Version 3.0)". The FDA issued a decision of Substantially Equivalent on October 19, 2018. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Invivo Corporation has at least 10 other 510(k) clearances on record.