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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