X-MIND optima XMO 2D WALL 100-240V
X-MIND optima XMO 2D WALL 100-240V (W1203001) is a Class II device made by De Götzen SRL, cleared under FDA 510(k) K203374 on 5 Feb 2021 and listed in FDA GUDID since 30 Jul 2024 (UDI-DI D804W12030010), active as of 22 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 | NumberD804W12030010 | Date30 Jul 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203374 | Date5 Feb 2021 | StatusActive |
Official records
- FDA 510(k) database K203374
Across registries
- FDA 510(k) K203374 decided 5 Feb 2021 Active
- FDA GUDID UDI-DI D804W12030010 listed 30 Jul 2024 Listed
Timeline
- Cleared FDA 510(k) K203374
- Listed FDA GUDID D804W12030010
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- X-MIND optima
- Generic name
- Stationary panoramic/tomographic dental x-ray system, digital
- Model / Ref / Catalog
- XMO 2D WALL 100-240V, W1203001
- Primary DI / UDI-DI
- D804W12030010
- 510(k) Number
- 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
- In Commercial Distribution
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