510(k) K201340

AQUILA 320 D / AQUILA 320 S by Vmi Tecnologias Ltda — Product Code IZL

K201340 is an FDA 510(k) premarket notification submitted by Vmi Tecnologias Ltda for the device "AQUILA 320 D / AQUILA 320 S". The FDA issued a decision of Substantially Equivalent on June 19, 2020. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Vmi Tecnologias Ltda has at least 2 other 510(k) clearances on record.