Bi-Image-X Evolution Mobile EL-X30070
by Dpm USA Corp
Bi-Image-X Evolution Mobile EL-X30070 (PC17B) is a Class II device made by Dpm USA Corp, cleared under FDA 510(k) K160458 on 20 Jun 2016 and listed in FDA GUDID since 8 Nov 2017 (UDI-DI 10850786008021), active as of 23 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 | Number10850786008021 | Date8 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160458 | Date20 Jun 2016 | StatusActive |
Official records
- AccessGUDID record 10850786008021
- FDA 510(k) database K160458
Across registries
- FDA 510(k) K160458 decided 20 Jun 2016 Active
- FDA GUDID UDI-DI 10850786008021 listed 8 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K160458
- Listed FDA GUDID 10850786008021
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bi-Image-X Evolution Mobile
- Generic name
- Stationary extraoral dental x-ray system, digital
- Model / Ref / Catalog
- EL-X30070, PC17B
- Primary DI / UDI-DI
- 10850786008021
- 510(k) Number
- FDA product code
- EHD
- GMDN term
- Stationary extraoral dental x-ray system, digital
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
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