Owandy Radiology Ow-RX
Owandy Radiology Ow-RX, a stationary intraoral dental x-ray system (FDA Class II; FDA product code EHD, Unit, X-Ray, Extraoral With Timer) made by Owandy Radiology, was listed in FDA GUDID on 24 Sep 2016 (UDI-DI 03760262650616); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03760262650616 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 03760262650616
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Owandy Radiology
- Generic name
- Stationary intraoral dental x-ray system, analogue
- Model / reference
- Ow-RX
- Primary DI / UDI-DI
- 03760262650616
- FDA product code
- EHD
- GMDN term
- Stationary intraoral dental x-ray system, analogue
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- Not in Commercial Distribution
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