510(k) K260205

AS Software Version Asera by AS Software, LLC — Product Code LLZ

K260205 is an FDA 510(k) premarket notification submitted by AS Software, LLC for the device "AS Software Version Asera". The FDA issued a decision of Substantially Equivalent on February 19, 2026. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. AS Software, LLC has at least 1 other 510(k) clearance on record.