Medical Device Manufacturer · FR , La Ricamarie

Stephanix - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2021

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Stephanix Radiology ✕

3 devices

1-3 of 3

Cleared Jun 07, 2022

D²RS and D²RS 9090

Radiology · 29d

Cleared Dec 23, 2021

D²RS and D²RS 9090

Radiology · 55d

Cleared Nov 03, 2021

Radiology · 85d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 19, 2026