Fona Xdc 9319001700
Fona Xdc 9319001700 is a Class II device made by Bluo Electronics SRL, cleared under FDA 510(k) K222274 on 23 Aug 2022 and listed in FDA GUDID since 6 Sep 2022 (UDI-DI E3159319001700), 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 | NumberE3159319001700 | Date6 Sep 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222274 | Date23 Aug 2022 | StatusActive |
Official records
- FDA 510(k) database K222274
Across registries
- FDA 510(k) K222274 decided 23 Aug 2022 Active
- FDA GUDID UDI-DI E3159319001700 listed 6 Sep 2022 Listed
Timeline
- Cleared FDA 510(k) K222274
- Listed FDA GUDID E3159319001700
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fona Xdc
- Generic name
- Stationary intraoral dental x-ray system, digital
- Model / reference
- 9319001700
- Primary DI / UDI-DI
- E3159319001700
- 510(k) Number
- FDA product code
- EHD
- GMDN term
- Stationary intraoral dental x-ray system, digital
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
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