RAYSCAN α-Expert3D 3D-CT, Pano
by Ray Co., Ltd
RAYSCAN α-Expert3D 3D-CT, Pano (3D-CT,Pano) is a Class II device made by Ray Co., Ltd, cleared under FDA 510(k) K190812 on 24 Apr 2019 and listed in FDA GUDID since 15 May 2019 (UDI-DI 08800003000159), 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 | Number08800003000159 | Date15 May 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190812 | Date24 Apr 2019 | StatusActive |
Official records
- AccessGUDID record 08800003000159
- FDA 510(k) database K190812
Across registries
- FDA 510(k) K190812 decided 24 Apr 2019 Active
- FDA GUDID UDI-DI 08800003000159 listed 15 May 2019 Listed
Timeline
- Cleared FDA 510(k) K190812
- Listed FDA GUDID 08800003000159
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- RAYSCAN α-Expert3D
- Generic name
- Stationary panoramic/tomographic dental x-ray system, digital
- Model / reference
- 3D-CT, Pano
- Primary DI / UDI-DI
- 08800003000159
- 510(k) Number
- FDA product code
- OAS
- GMDN term
- Stationary panoramic/tomographic dental x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution
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