510(k) Report

Devices descending from K180601

1 later device reach Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L.20200—