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FDA 510(k) Applications Submitted by Dario Bandiera
FDA 510(k) Number
Submission Date
Device Name
Applicant
K220426
02/14/2022
Fiber Dust PRO
Quanta System Spa
K201382
05/26/2020
X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)
de Gotzen S.r.l.
K191719
06/26/2019
X-MIND Trium
de Gotzen S.R.L
K192165
08/09/2019
Acteon Imaging Suite
de Gotzen S.R.L
K223404
11/09/2022
Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
Quanta System, S.p.A.
K203374
11/16/2020
X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)
de G÷tzen S.r.l.
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