Rayscan Α SM3D
by Ray Co., Ltd
Rayscan Α SM3D 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 08800003000081), 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 | Number08800003000081 | Date5 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142247 | Date17 Apr 2015 | StatusActive |
Official records
- AccessGUDID record 08800003000081
- FDA 510(k) database K142247
Across registries
- FDA 510(k) K142247 decided 17 Apr 2015 Active
- FDA GUDID UDI-DI 08800003000081 listed 5 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K142247
- Listed FDA GUDID 08800003000081
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- Withdrawn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
- SM3D
- Primary DI / UDI-DI
- 08800003000081
- 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
Similar devices in this category
Other devices filed under Stationary panoramic/tomographic dental x-ray system, digital.
- vatech A9 PHT-30CSS by VATECH CO., LTD.
- T2-CS by OSSTEM IMPLANT Co., Ltd.
- R2 STUDIO Q RCT820-SC by Megagen Implant Co., Ltd.
- PaX-i Plus PCH-30CS by VATECH CO., LTD.
- Veraviewepocs X550 by J.MORITA MFG.CORP.
- bright MCT ICT-R01-M by Dentium Co., Ltd.
- Axeos 6728922 by SIRONA Dental Systems GmbH
- R2 STUDIO Q RCT820 by Megagen Implant Co., Ltd.
- Axeos 6728914 by SIRONA Dental Systems GmbH