BI Image-X Evolution
by Radiotecnología Industrial, S.A. de C.V. 2 variants
BI Image-X Evolution is a Class II device made by Radiotecnología Industrial, S.A. de C.V., cleared under FDA 510(k) K160458 on 20 Jun 2016 and listed in FDA GUDID since 12 Sep 2017 (UDI-DI D881RXEMWEXP0), active as of 22 Oct 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 | NumberD881RXEMWEXP0 | Date12 Sep 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160458 | Date20 Jun 2016 | StatusActive |
Official records
- FDA 510(k) database K160458
Across registries
- FDA 510(k) K160458 decided 20 Jun 2016 Active
- FDA GUDID UDI-DI D881RXEMWEXP0 listed 12 Sep 2017 Listed
Timeline
- Cleared FDA 510(k) K160458
- Listed FDA GUDID D881RXEMWEXP0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BI Image-X
- Generic name
- Stationary extraoral dental x-ray system, analogue
- Model / reference
- Evolution
- Primary DI / UDI-DI
- D881RXEMWEXP0
- 510(k) Number
- FDA product code
- EHD
- GMDN term
- Stationary extraoral dental x-ray system, analogue
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
- Size
- Angle — 180 degreeLength — 2.2 MeterHeight — 2 Meter
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