IntraOs DG 9325001300
IntraOs DG 9325001300 is a Class II device made by Bluo Electronics SRL, cleared under FDA 510(k) K031118 on 8 Jul 2003 and listed in FDA GUDID since 10 Sep 2016 (UDI-DI E31593250013000), 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 | NumberE31593250013000 | Date10 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031118 | Date8 Jul 2003 | StatusActive |
Official records
- FDA 510(k) database K031118
Across registries
- FDA 510(k) K031118 decided 8 Jul 2003 Active
- FDA GUDID UDI-DI E31593250013000 listed 10 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K031118
- Listed FDA GUDID E31593250013000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- IntraOs DG
- Generic name
- Mobile intraoral dental x-ray system, digital
- Model / reference
- 9325001300
- Primary DI / UDI-DI
- E31593250013000
- 510(k) Number
- FDA product code
- EHD
- GMDN term
- Mobile intraoral dental x-ray system, digital
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
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