FDA 510(k) Applications Submitted by de Gotzen S.r.l.

FDA 510(k) Number Submission Date Device Name Applicant
K201382 05/26/2020 X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) de Gotzen S.r.l.
K132378 07/31/2013 X-MIND UNITY DE GOTZEN S.R.L.
K160166 01/27/2016 X-MIND trium DE GOTZEN S.R.L.


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