510(k) K231709

AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 by Radmedix, LLC — Product Code MQB

K231709 is an FDA 510(k) premarket notification submitted by Radmedix, LLC for the device "AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4". The FDA issued a decision of Substantially Equivalent on July 12, 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. Radmedix, LLC has at least 5 other 510(k) clearances on record.