# Kubtec Xpert 20

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/kubtec-xpert-20-kpr>
- Manufacturer: [Kub Technologies, Inc.](https://devicerts.com/manufacturers/kub-technologies-inc) (United States)
- Name in the registry: KUBTEC XPERT 20
- Device class: Class II (US FDA)
- FDA product code: KPR

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K083510 · decision 2009-01-08 · decision SESE · status: Active
- **EUDAMED** · CE/MDR · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K083510 [FDA 510(k)]
- FDA product code: KPR [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.1680 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Kubtec Xpert 20, Kub Technologies, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/kubtec-xpert-20-kpr (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/kubtec-xpert-20-kpr.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/kubtec-xpert-20-kpr
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.