510(k) K244049

Europa (Alternative: AiRTouch) portable X-ray system by Livermoretech, Inc. — Product Code IZL

K244049 is an FDA 510(k) premarket notification submitted by Livermoretech, Inc. for the device "Europa (Alternative: AiRTouch) portable X-ray system". The FDA issued a decision of Substantially Equivalent on May 28, 2025. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Livermoretech, Inc. has at least 5 other 510(k) clearances on record.