510(k) K231761

PodSKAN HF Diagnostic X-ray System by Skanray Technologies Limited — Product Code KPR

K231761 is an FDA 510(k) premarket notification submitted by Skanray Technologies Limited for the device "PodSKAN HF Diagnostic X-ray System". The FDA issued a decision of Substantially Equivalent on October 27, 2023. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Skanray Technologies Limited has at least 3 other 510(k) clearances on record.