X-MIND trium XMT PAN 3D READY L
X-MIND trium XMT PAN 3D READY L (W0900226) is a Class II device made by De Götzen SRL, cleared under FDA 510(k) K160166 on 15 Nov 2016 and listed in FDA GUDID since 15 Dec 2016 (UDI-DI D804W09002260), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | NumberD804W09002260 | Date15 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160166 | Date15 Nov 2016 | StatusActive |
Official records
- FDA 510(k) database K160166
Across registries
- FDA 510(k) K160166 decided 15 Nov 2016 Active
- FDA GUDID UDI-DI D804W09002260 listed 15 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K160166
- Listed FDA GUDID D804W09002260
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- X-MIND trium
- Generic name
- Cone beam computed tomography system, head/neck
- Model / Ref / Catalog
- XMT PAN 3D READY L, W0900226
- Primary DI / UDI-DI
- D804W09002260
- 510(k) Number
- FDA product code
- MUH, OAS
- GMDN term
- Cone beam computed tomography system, head/neck
- Device class
- Class II
- Regulation number
- 872.1800, 892.1750
- GUDID distribution status
- Not in Commercial Distribution
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