Medical Device Manufacturer · IT , Assago

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

4 submissions · 4 cleared · Since 2016

4

Total

4

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Aug 23, 2022

Radiology · 25d

Cleared Mar 02, 2022

Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph

Radiology · 112d

Cleared Aug 30, 2021

StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2

Radiology · 55d

Cleared Nov 03, 2016

Radiology · 196d