510(k) K230918

MasterX 800 Series by Medicatech USA — Product Code MQB

K230918 is an FDA 510(k) premarket notification submitted by Medicatech USA for the device "MasterX 800 Series". The FDA issued a decision of Substantially Equivalent on September 1, 2023. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Medicatech USA has at least 9 other 510(k) clearances on record.