Owandy Radiology ONE #1
Owandy Radiology ONE #1 (9458600100) is a Class II device made by Owandy Radiology, cleared under FDA 510(k) K133271 on 28 Apr 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 03760262651118), 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 | Number03760262651118 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133271 | Date28 Apr 2014 | StatusActive |
Official records
- AccessGUDID record 03760262651118
- FDA 510(k) database K133271
Across registries
- FDA 510(k) K133271 decided 28 Apr 2014 Active
- FDA GUDID UDI-DI 03760262651118 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K133271
- Listed FDA GUDID 03760262651118
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Owandy Radiology
- Generic name
- Dental digital imaging sensor, intraoral
- Model / Ref / Catalog
- ONE #1, 9458600100
- Primary DI / UDI-DI
- 03760262651118
- 510(k) Number
- FDA product code
- MUH
- GMDN term
- Dental digital imaging sensor, intraoral
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
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