AIOBIO Qraypen
AIOBIO Qraypen is a Class I device made by AIOBIO Co., Ltd., cleared under FDA 510(k) K183121 on 18 Jul 2019 and listed in FDA GUDID since 29 May 2024 (UDI-DI 08800043200038), 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 | Number08800043200038 | Date29 May 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK183121 | Date18 Jul 2019 | StatusActive |
Official records
- AccessGUDID record 08800043200038
- FDA 510(k) database K183121
Across registries
- FDA 510(k) K183121 decided 18 Jul 2019 Active
- FDA GUDID UDI-DI 08800043200038 listed 29 May 2024 Listed
Timeline
- Cleared FDA 510(k) K183121
- Listed FDA GUDID 08800043200038
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aiobio
- Generic name
- Intraoral camera
- Model / reference
- Qraypen
- Primary DI / UDI-DI
- 08800043200038
- 510(k) Number
- FDA product code
- EIA
- GMDN term
- Intraoral camera
- Device class
- Class I
- Regulation number
- 872.6640
- GUDID distribution status
- In Commercial Distribution
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