Eos® 3.4
by Eos Imaging
Eos® 3.4 is a Class II device made by Eos Imaging, cleared under FDA 510(k) K152788 on 21 Oct 2015 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 03663999000016), 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 | Number03663999000016 | Date21 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152788 | Date21 Oct 2015 | StatusActive |
Official records
- AccessGUDID record 03663999000016
- FDA 510(k) database K152788
Across registries
- FDA 510(k) K152788 decided 21 Oct 2015 Active
- FDA GUDID UDI-DI 03663999000016 listed 21 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K152788
- Listed FDA GUDID 03663999000016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Eos®
- Generic name
- Stationary basic diagnostic x-ray system, digital
- Model / reference
- 3.4
- Primary DI / UDI-DI
- 03663999000016
- 510(k) Number
- FDA product code
- KPR
- GMDN term
- Stationary basic diagnostic x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
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