Rayscan Α M3DL
by Ray Co., Ltd
Rayscan Α M3DL is a Class II device made by Ray Co., Ltd, cleared under FDA 510(k) K142247 on 17 Apr 2015 and listed in FDA GUDID since 5 Oct 2016 (UDI-DI 08800003000098), 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 | Number08800003000098 | Date5 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142247 | Date17 Apr 2015 | StatusActive |
Official records
- AccessGUDID record 08800003000098
- FDA 510(k) database K142247
Across registries
- FDA 510(k) K142247 decided 17 Apr 2015 Active
- FDA GUDID UDI-DI 08800003000098 listed 5 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K142247
- Listed FDA GUDID 08800003000098
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Rayscan Α
- Generic name
- Stationary panoramic/tomographic dental x-ray system, digital
- Model / reference
- M3DL
- Primary DI / UDI-DI
- 08800003000098
- 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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