Rayscan Α + RCT700-Ct
by Ray Co., Ltd
Rayscan Α + RCT700-Ct is a Class II device made by Ray Co., Ltd, cleared under FDA 510(k) K182614 on 16 Oct 2018 and listed in FDA GUDID since 7 Nov 2018 (UDI-DI 08800003001187), 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 | Number08800003001187 | Date7 Nov 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182614 | Date16 Oct 2018 | StatusActive |
Official records
- AccessGUDID record 08800003001187
- FDA 510(k) database K182614
Across registries
- FDA 510(k) K182614 decided 16 Oct 2018 Active
- FDA GUDID UDI-DI 08800003001187 listed 7 Nov 2018 Listed
Timeline
- Cleared FDA 510(k) K182614
- Listed FDA GUDID 08800003001187
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- Withdrawn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-CT
- Primary DI / UDI-DI
- 08800003001187
- 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.
- Axeos 6728914 by SIRONA Dental Systems GmbH
- Axeos 6728930 by SIRONA Dental Systems GmbH
- 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.
- R2 STUDIO Q RCT820 by Megagen Implant Co., Ltd.