510(k) K171885

Radiance V4 by Gmv Soluciones Globales Internet S.A.U. — Product Code MUJ

K171885 is an FDA 510(k) premarket notification submitted by Gmv Soluciones Globales Internet S.A.U. for the device "Radiance V4". The FDA issued a decision of Substantially Equivalent on July 25, 2017. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Gmv Soluciones Globales Internet S.A.U. has at least 3 other 510(k) clearances on record.