510(k) K213081

CLISIS SYSTEMS, Discovery RF180 by General Medical Merate S.P.A — Product Code IZF

K213081 is an FDA 510(k) premarket notification submitted by General Medical Merate S.P.A for the device "CLISIS SYSTEMS, Discovery RF180". The FDA issued a decision of Substantially Equivalent on October 26, 2021. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. General Medical Merate S.P.A has at least 6 other 510(k) clearances on record.