AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4

AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 is an FDA 510(k)-cleared medical device (K231709) manufactured by Radmedix, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 11, 2023. Regulation: 8.