510(k) K173395

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

K173395 is an FDA 510(k) premarket notification submitted by General Medical Merate S.P.A for the device "MECALL CLISIS SYSTEMS, Discovery RF180". The FDA issued a decision of Substantially Equivalent on May 21, 2018. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. General Medical Merate S.P.A has at least 6 other 510(k) clearances on record.