Rayscan Α+ RCT700-Sc+ent
by Ray Co., Ltd
Rayscan Α+ RCT700-Sc+ent is a Class II device made by Ray Co., Ltd, cleared under FDA 510(k) K213226 on 29 Nov 2021 and listed in FDA GUDID since 2 May 2022 (UDI-DI 08800003001323), 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 | Number08800003001323 | Date2 May 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213226 | Date29 Nov 2021 | StatusActive |
Official records
- AccessGUDID record 08800003001323
- FDA 510(k) database K213226
Across registries
- FDA 510(k) K213226 decided 29 Nov 2021 Active
- FDA GUDID UDI-DI 08800003001323 listed 2 May 2022 Listed
Timeline
- Cleared FDA 510(k) K213226
- Listed FDA GUDID 08800003001323
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- Withdrawn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
- RCT700-SC+ENT
- Primary DI / UDI-DI
- 08800003001323
- 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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