510(k) K161345

RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR by Sedecal., Sa. — Product Code IZL

K161345 is an FDA 510(k) premarket notification submitted by Sedecal., Sa. for the device "RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR". The FDA issued a decision of Substantially Equivalent on July 6, 2016. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Sedecal., Sa. has at least 10 other 510(k) clearances on record.