Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard

Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard is an FDA 510(k)-cleared medical device (K193360) 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 January 1, 2020. Regulation: 8.