Owandy Radiology I-Max Touch
Owandy Radiology I-Max Touch is a Class II device made by Owandy Radiology, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 03760262650012), 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 | Number03760262650012 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 03760262650012
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Owandy Radiology
- Generic name
- Stationary panoramic/tomographic dental x-ray system, digital
- Model / reference
- I-Max Touch
- Primary DI / UDI-DI
- 03760262650012
- FDA product code
- MUH
- GMDN term
- Stationary panoramic/tomographic dental x-ray system, digital
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- Not in Commercial Distribution
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