Kubtec X250
510(k) K141539
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141539 | Date29 Oct 2014 | StatusActive |
Official records
- FDA 510(k) database K141539
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IZL
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1720
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Kubtec X250 is a mobile X-ray system designed for radiologic imaging. It is classified as a mobile X-ray system under the nomenclature for radiographic imaging equipment, providing portable radiographic capabilities for clinical use.
This device is intended for single-use or reusable applications in radiology settings, depending on facility protocols. It is regulated under 21 CFR 892.1720 and holds FDA 510(k) clearance (K141539) for use as a Class II medical device. The Kubtec X250 is supplied with various FEI numbers and registration identifiers, ensuring compliance with regulatory requirements.
From the manufacturer
About KUBTEC® At KUBTEC®, our passion is developing transformative technologies that enable precision cancer surgery. For nearly 20 years, we have led the way in specimen imaging technology, and now we also offer an innovative gamma probe detection system that seamlessly integrates with our imaging solutions.
Devices cleared under K141539
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 | |||
|---|---|---|---|---|
| KUBTEC KUB250 | KUB250 | B619KUB2500 | — | On the market |
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Other devices filed under FDA product code IZL (System, X-Ray, Mobile).
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