510(k) K170172

UNiD Spine Analyzer by Medicrea International — Product Code LLZ

K170172 is an FDA 510(k) premarket notification submitted by Medicrea International for the device "UNiD Spine Analyzer". The FDA issued a decision of Substantially Equivalent on May 24, 2017. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Medicrea International has at least 10 other 510(k) clearances on record.