MiniCAT 10004
MiniCAT 10004 is a Class II device made by Xoran Technologies, LLC, cleared under FDA 510(k) K113421 on 11 Jul 2012 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00860290000308), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00860290000308 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113421 | Date11 Jul 2012 | StatusActive |
Official records
- AccessGUDID record 00860290000308
- FDA 510(k) database K113421
Across registries
- FDA 510(k) K113421 decided 11 Jul 2012 Active
- FDA GUDID UDI-DI 00860290000308 listed 20 Sep 2016 Listed
Recalls
-
- Terminated Z-1210-2015
Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.
Timeline
- Cleared FDA 510(k) K113421
- Recall initiated FDA recalls Z-1210-2015
- Listed FDA GUDID 00860290000308
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MiniCAT
- Generic name
- Cone beam computed tomography system, head/neck
- Model / reference
- 10004
- Primary DI / UDI-DI
- 00860290000308
- 510(k) Number
- FDA product code
- JAK
- GMDN term
- Cone beam computed tomography system, head/neck
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution
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