510(k) K162190

Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) by Villa Sistemi Medicali S.P.A. — Product Code MUH

K162190 is an FDA 510(k) premarket notification submitted by Villa Sistemi Medicali S.P.A. for the device "Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)". The FDA issued a decision of Substantially Equivalent on July 6, 2017. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Villa Sistemi Medicali S.P.A. has at least 10 other 510(k) clearances on record.