510(k) K222035

Avatar Medical Software V1 by Avatar Medical — Product Code LLZ

K222035 is an FDA 510(k) premarket notification submitted by Avatar Medical for the device "Avatar Medical Software V1". The FDA issued a decision of Substantially Equivalent on May 24, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Avatar Medical has at least 3 other 510(k) clearances on record.