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Kubtec Xpert 20

by Kub Technologies, Inc.

510(k) K083510

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K083510↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK083510 Date8 Jan 2009ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083510 decided 8 Jan 2009 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Devices cleared under K083510

2 devices · FDA GUDID

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.

Devices cleared under K083510
UDI-DISize and differences
KUBTEC XPERT 20
Kubtec
XPERT 20B619X200 —On the market
XPERT20 XPERT 20
Kubtec
XPERT 20B619X20Q9 —On the market

Similar devices

Other devices filed under FDA product code KPR (System, X-Ray, Stationary).

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