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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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