510(k) K212175

DynaCAD by Invivo Corporation — Product Code LLZ

K212175 is an FDA 510(k) premarket notification submitted by Invivo Corporation for the device "DynaCAD". The FDA issued a decision of Substantially Equivalent on August 2, 2021. 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.