Medical Device Manufacturer · US , Grass Valley , CA

Eigen, LLC - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2008

Recent clearances: DSA 2000EX, 3-D IMAGING WORKSTATION

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Eigen, LLC Radiology ✕

2 devices

1-2 of 2

Cleared Aug 29, 2008

Radiology · 14d

Cleared May 01, 2008

3-D IMAGING WORKSTATION

Radiology · 14d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Oct 01, 2026