510(k) K251443

PROMO by DRGEM Corporation — Product Code IZL

K251443 is an FDA 510(k) premarket notification submitted by DRGEM Corporation for the device "PROMO". The FDA issued a decision of Substantially Equivalent on August 22, 2025. 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.