510(k) K193360

Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard by Radmedix, LLC — Product Code KPR

K193360 is an FDA 510(k) premarket notification submitted by Radmedix, LLC for the device "Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard". The FDA issued a decision of Substantially Equivalent on January 2, 2020. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Radmedix, LLC has at least 5 other 510(k) clearances on record.