510(k) K203537

Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems by Sedecal., Sa. — Product Code KPR

K203537 is an FDA 510(k) premarket notification submitted by Sedecal., Sa. for the device "Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems". The FDA issued a decision of Substantially Equivalent on February 1, 2021. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Sedecal., Sa. has at least 10 other 510(k) clearances on record.