MiniCAT 2D 10035
MiniCAT 2D 10035 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 26 Jul 2023 (UDI-DI 00860008443724), 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 | Number00860008443724 | Date26 Jul 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201825 | Date20 Nov 2020 | StatusActive |
Official records
- AccessGUDID record 00860008443724
- FDA 510(k) database K201825
Across registries
- FDA 510(k) K201825 decided 20 Nov 2020 Active
- FDA GUDID UDI-DI 00860008443724 listed 26 Jul 2023 Listed
Timeline
- Cleared FDA 510(k) K201825
- Listed FDA GUDID 00860008443724
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- Withdrawn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
- 10035
- Primary DI / UDI-DI
- 00860008443724
- 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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