510(k) K221081

iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System by First Source, Inc. — Product Code IZL

K221081 is an FDA 510(k) premarket notification submitted by First Source, Inc. for the device "iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System". The FDA issued a decision of Substantially Equivalent on June 13, 2022. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. First Source, Inc. has at least 2 other 510(k) clearances on record.