510(k) K212940

Skanmobile, Skanmobile-Dr by Skanray Technologies Limited — Product Code IZL

K212940 is an FDA 510(k) premarket notification submitted by Skanray Technologies Limited for the device "Skanmobile, Skanmobile-Dr". The FDA issued a decision of Substantially Equivalent on March 4, 2022. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Skanray Technologies Limited has at least 3 other 510(k) clearances on record.