510(k) K192541

DigiX FDX by Allengers Medical Systems Limited — Product Code KPR

K192541 is an FDA 510(k) premarket notification submitted by Allengers Medical Systems Limited for the device "DigiX FDX". The FDA issued a decision of Substantially Equivalent on October 16, 2019. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Allengers Medical Systems Limited has at least 7 other 510(k) clearances on record.