510(k) K211542

PRIMO S by A.T.S. Applicazione Tecnologie Speciali S.R.L. — Product Code MQB

K211542 is an FDA 510(k) premarket notification submitted by A.T.S. Applicazione Tecnologie Speciali S.R.L. for the device "PRIMO S". The FDA issued a decision of Substantially Equivalent on July 9, 2021. 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. A.T.S. Applicazione Tecnologie Speciali S.R.L. has at least 3 other 510(k) clearances on record.