MiniCAT 2D 10030
MiniCAT 2D 10030 is a stationary basic diagnostic x-ray system (FDA Class II; FDA product code KPR, System, X-Ray, Stationary) made by Xoran Technologies, LLC, cleared under FDA 510(k) K201825 on 20 Nov 2020 and listed in FDA GUDID since 14 Dec 2020 (UDI-DI 00860290000377), 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 | Number00860290000377 | Date14 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201825 | Date20 Nov 2020 | StatusActive |
Official records
- AccessGUDID record 00860290000377
- FDA 510(k) database K201825
Across registries
- FDA 510(k) K201825 decided 20 Nov 2020 Active
- FDA GUDID UDI-DI 00860290000377 listed 14 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K201825
- Listed FDA GUDID 00860290000377
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MiniCAT 2D
- Generic name
- Stationary basic diagnostic x-ray system, digital
- Model / reference
- 10030
- Primary DI / UDI-DI
- 00860290000377
- 510(k) Number
- FDA product code
- KPR
- GMDN term
- Stationary basic diagnostic x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
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