Owandy-RX PRO CORE KIT SC NO BRACKET
Owandy-RX PRO CORE KIT SC NO BRACKET (W0806091) is a Class II device made by Owandy Radiology, cleared under FDA 510(k) K132378 on 30 May 2014 and listed in FDA GUDID since 7 Oct 2022 (UDI-DI 03760262650661), 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 | Number03760262650661 | Date7 Oct 2022 | StatusListed |
| United States | FDA 510(k) | NumberK132378 | Date30 May 2014 | StatusActive |
Official records
- AccessGUDID record 03760262650661
- FDA 510(k) database K132378
Across registries
- FDA 510(k) K132378 decided 30 May 2014 Active
- FDA GUDID UDI-DI 03760262650661 listed 7 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K132378
- Listed FDA GUDID 03760262650661
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Owandy-RX PRO
- Generic name
- Stationary intraoral dental x-ray system, digital
- Model / Ref / Catalog
- Owandy-RX PRO CORE KIT SC NO BRACKET, W0806091
- Primary DI / UDI-DI
- 03760262650661
- 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
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