510(k) K260085

RAYMO Mobile X-ray System (Model: RAYMO) by DRGEM Corporation — Product Code IZL

K260085 is an FDA 510(k) premarket notification submitted by DRGEM Corporation for the device "RAYMO Mobile X-ray System (Model: RAYMO)". The FDA issued a decision of Substantially Equivalent on May 14, 2026. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. DRGEM Corporation has at least 10 other 510(k) clearances on record.