Medical Device Manufacturer · IT , Olgiate Olona, Varese

De Gotzen S.R.L. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2014

Recent clearances: X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology), X-MIND Trium, Acteon Imaging Suite

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - De Gotzen S.R.L. Radiology ✕

5 devices

1-5 of 5

Cleared Nov 18, 2020

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy...

Radiology · 176d

Cleared Feb 20, 2020

Radiology · 239d

Cleared Feb 11, 2020

Acteon Imaging Suite

Radiology · 186d

Cleared Nov 15, 2016

Radiology · 293d

Cleared May 30, 2014

Radiology · 303d