sterEOS® Software 1.6
by Eos Imaging
sterEOS® Software 1.6 is a Class II device made by Eos Imaging, cleared under FDA 510(k) K141137 on 15 Sep 2014 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 03663999000030), active as of 12 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03663999000030 | Date21 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141137 | Date15 Sep 2014 | StatusActive |
Official records
- AccessGUDID record 03663999000030
- FDA 510(k) database K141137
Across registries
- FDA 510(k) K141137 decided 15 Sep 2014 Active
- FDA GUDID UDI-DI 03663999000030 listed 21 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K141137
- Listed FDA GUDID 03663999000030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- sterEOS®
- Generic name
- Basic x-ray clinical assessment support software
- Model / reference
- Software 1.6
- Primary DI / UDI-DI
- 03663999000030
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Basic x-ray clinical assessment support software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Basic diagnostic x-ray system application software.