AutoDensity 1.3
by Eos Imaging
AutoDensity 1.3 is a Class II device made by Eos Imaging, cleared under FDA 510(k) K251078 on 14 Nov 2025 and listed in FDA GUDID since 9 Dec 2025 (UDI-DI 03663999000436), 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 | Number03663999000436 | Date9 Dec 2025 | StatusListed |
| United States | FDA 510(k) | NumberK251078 | Date14 Nov 2025 | StatusActive |
Official records
- AccessGUDID record 03663999000436
- FDA 510(k) database K251078
Across registries
- FDA 510(k) K251078 decided 14 Nov 2025 Active
- FDA GUDID UDI-DI 03663999000436 listed 9 Dec 2025 Listed
Timeline
- Cleared FDA 510(k) K251078
- Listed FDA GUDID 03663999000436
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AutoDensity
- Generic name
- Basic x-ray clinical assessment support software
- Model / reference
- 1.3
- Primary DI / UDI-DI
- 03663999000436
- 510(k) Number
- FDA product code
- QIH
- GMDN term
- Basic x-ray clinical assessment support software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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