Rayscan Α
by Ray Co., Ltd
Rayscan Α is a Class II device made by Ray Co., Ltd, cleared under FDA 510(k) K142058 on 22 Apr 2015 and listed in FDA GUDID since 5 Oct 2016 (UDI-DI 08800003000036), active as of 8 Jun 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 | Number08800003000036 | Date5 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142058 | Date22 Apr 2015 | StatusActive |
Official records
- AccessGUDID record 08800003000036
- FDA 510(k) database K142058
Across registries
- FDA 510(k) K142058 decided 22 Apr 2015 Active
- FDA GUDID UDI-DI 08800003000036 listed 5 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K142058
- Listed FDA GUDID 08800003000036
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Stationary panoramic/tomographic dental x-ray system, digital
- Model / reference
- SC
- Primary DI / UDI-DI
- 08800003000036
- 510(k) Number
- FDA product code
- MUH
- GMDN term
- Stationary panoramic/tomographic dental x-ray system, digital
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
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