US device clearances
2 510(k) clearances and PMA approvals since 2015
- X-Mind Dc (Under Trademark Acteon), Owandy-Rx Dc (Under Trademark Owandyradiolo… K231055 · 28 Dec 2023
- X-Mind Prime (Under Trade Mark Acteon), I-Max (Under Trade Mark Owandy Radiolog… K203374 · 5 Feb 2021
Source: FDA 510(k) and PMA databases, 510(k) clearances, and PMA approvals or changes, since 2015; newest shown. Retrieved 13 Nov 2026.