myray RX DC
by Cefla Societa' Cooperativa 8 variants
myray RX DC (706G0011) is a Class II device made by Cefla Societa' Cooperativa, cleared under FDA 510(k) K163519 on 13 Jan 2017 and listed in FDA GUDID since 31 Aug 2017 (UDI-DI 08033837931621), 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 | Number08033837931621 | Date31 Aug 2017 | StatusListed |
| United States | FDA 510(k) | NumberK163519 | Date13 Jan 2017 | StatusActive |
Official records
- AccessGUDID record 08033837931621
- FDA 510(k) database K163519
Across registries
- FDA 510(k) K163519 decided 13 Jan 2017 Active
- FDA GUDID UDI-DI 08033837931621 listed 31 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K163519
- Listed FDA GUDID 08033837931621
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- myray
- Generic name
- Stationary intraoral dental x-ray system, digital
- Model / Ref / Catalog
- RX DC, 706G0011
- Primary DI / UDI-DI
- 08033837931621
- 510(k) Number
- FDA product code
- EHD
- GMDN term
- Stationary intraoral dental x-ray system, digital
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code EHD (Unit, X-Ray, Extraoral With Timer).
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- Orthophos E 6707470 by SIRONA Dental Systems GmbH
- AXIAL TOME, 60, FLUORO AND TOMAX by Axialtome Corp.
- REMEX-GR100 by REMEDI CO., LTD.
- KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER by EASTMAN KODAK COMPANY
- Portable X-ray System (Model: MiniX-V, Mini X-S) by DigiMed Co., Ltd.