xCAT 11000
xCAT 11000 is a Class II device made by Xoran Technologies, LLC, cleared under FDA 510(k) K061834 on 7 Aug 2006 and listed in FDA GUDID since 28 Jun 2017 (UDI-DI 00860290000339), 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 | Number00860290000339 | Date28 Jun 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061834 | Date7 Aug 2006 | StatusActive |
Official records
- AccessGUDID record 00860290000339
- FDA 510(k) database K061834
Across registries
- FDA 510(k) K061834 decided 7 Aug 2006 Active
- FDA GUDID UDI-DI 00860290000339 listed 28 Jun 2017 Listed
Timeline
- Cleared FDA 510(k) K061834
- Listed FDA GUDID 00860290000339
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- xCAT
- Generic name
- Cone beam computed tomography system, head/neck
- Model / reference
- 11000
- Primary DI / UDI-DI
- 00860290000339
- 510(k) Number
- FDA product code
- IZL
- GMDN term
- Cone beam computed tomography system, head/neck
- Device class
- Class II
- Regulation number
- 892.1720
- GUDID distribution status
- In Commercial Distribution
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