RIOSensor RIO500 (size 1)
by Ray Co., Ltd
RIOSensor RIO500 (size 1) is a dental digital imaging sensor (FDA Class II; FDA product code MQB, Solid State X-Ray Imager (Flat Panel/Digital Imager)) made by Ray Co., Ltd, cleared under FDA 510(k) K143000 on 23 Jan 2015 and listed in FDA GUDID since 5 Oct 2016 (UDI-DI 08800003002016), 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 | Number08800003002016 | Date5 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143000 | Date23 Jan 2015 | StatusActive |
Official records
- AccessGUDID record 08800003002016
- FDA 510(k) database K143000
Across registries
- FDA 510(k) K143000 decided 23 Jan 2015 Active
- FDA GUDID UDI-DI 08800003002016 listed 5 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K143000
- Listed FDA GUDID 08800003002016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- RIOSensor
- Generic name
- Dental digital imaging sensor, intraoral
- Model / reference
- RIO500 (size 1)
- Primary DI / UDI-DI
- 08800003002016
- 510(k) Number
- FDA product code
- MQB
- GMDN term
- Dental digital imaging sensor, intraoral
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
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