510(k) K203374

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) by De Götzen S.R.L. — Product Code MUH

K203374 is an FDA 510(k) premarket notification submitted by De Götzen S.R.L. for the device "X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)". The FDA issued a decision of Substantially Equivalent on February 5, 2021. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. De Götzen S.R.L. has at least 1 other 510(k) clearance on record.