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Kubtec Xpert 20

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K083510

by Kub Technologies, Inc.

Identifiers

510(k) Number
K083510 FDA 510(k)
FDA Product Code
KPR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1680 FDA 510(k)
Regulation Number
892.1680 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Kubtec Xpert 20 is a stationary X-ray system designed for radiologic imaging. It is classified as a Class II medical device and operates as a fixed-position radiographic unit, enabling high-resolution imaging for diagnostic purposes in radiology settings.

The device is supplied as a reusable system and is intended for use in controlled clinical environments such as hospitals or radiology clinics. It is not MRI-safe and requires proper storage and maintenance per manufacturer guidelines. Authorized under FDA 510(k) clearance and MDR compliance, the Kubtec Xpert 20 is regulated under the classification code 892.1680.

Frequently asked questions

Is the Kubtec Xpert 20 designed for portable use or is it a fixed-position system in radiology settings?

The Kubtec Xpert 20 is explicitly described as a fixed-position radiographic unit, meaning it is not portable and must remain stationary in its designated location within radiology environments like hospitals or clinics. Its design ensures stability for high-resolution imaging but does not allow for mobility between different examination areas.

How is the Kubtec Xpert 20 regulated, and what does that mean for purchasing or clinical use?

The Kubtec Xpert 20 is regulated under FDA 510(k) clearance and MDR compliance, classified as a Class II medical device with the product code KPR and regulation number 892.1680. This means it has undergone premarket review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets safety and performance standards for stationary X-ray imaging in radiology. Purchasers should confirm compliance with local regulations, as this classification applies to its intended use in controlled clinical environments.

Can the Kubtec Xpert 20 be reused, or is it intended for single-use applications?

The Kubtec Xpert 20 is not a single-use device—it is explicitly described as a reusable system designed for long-term use in radiology settings. Reuse requires adherence to the manufacturer’s maintenance guidelines to ensure proper functionality, safety, and image quality over time. Sterility is not applicable to the system itself, but any disposable components (e.g., cassettes or detectors) would follow separate sterilization protocols if used.

What special considerations should be taken into account when storing the Kubtec Xpert 20?

The Kubtec Xpert 20 requires proper storage and maintenance as outlined by the manufacturer to preserve its performance and longevity. Since it is a fixed-position system, storage primarily involves environmental controls (e.g., temperature, humidity, and protection from physical damage) in its designated radiology space. The device is not MRI-safe, so storage areas must avoid electromagnetic interference from MRI equipment. Regular servicing is critical to ensure calibration and reliability.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kub Technologies, Inc.

Sources (2)

  • FDA 510(k) K083510 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026