MiniCAT 2D
510(k) K201825
MiniCAT 2D is a medical device (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, 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 | FDA 510(k)SESE | NumberK201825 | Date20 Nov 2020 | StatusActive |
Official records
- FDA 510(k) database K201825
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPR
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K201825
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| MiniCAT 2D 10030 | 10030 | 00860290000377 | — | On the market |
| MiniCAT 2D 10031 | 10031 | 00860008443748 | — | On the market |
| MiniCAT 2D 10035 | 10035 | 00860008443724 | — | On the market |
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