510(k) K222195

aprevo® Digital Workflow by Carlsmed, Inc. — Product Code LLZ

K222195 is an FDA 510(k) premarket notification submitted by Carlsmed, Inc. for the device "aprevo® Digital Workflow". The FDA issued a decision of Substantially Equivalent on December 30, 2022. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Carlsmed, Inc. has at least 10 other 510(k) clearances on record.