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Xrt 400

by Wuestec Medical, Inc.

510(k) K955414

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955414 Date24 Jul 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KXJ
Device Class
Class II
Regulation
21 CFR Part 892.1980
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Xrt 400 is a radiologic table, a device intended for medical purposes to support a patient during radiologic procedures. It may be fixed or tilting and may be electrically powered.

The Xrt 400 is supplied with FDA 510K authorizations and is classified as a Class II device with special controls. It is used in the field of Radiology and has a product code of KXJ. The device has a registration number and is subject to certain regulations, including 892.1980.

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Questions

AI-generated answers, 24 Sep 2026

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

  • What is the XRT 400 used for?

    The XRT 400 is used to support patients during radiologic procedures, and may be fixed or tilting, with optional electrical power.

  • Is the XRT 400 supplied sterile?

    The device data does not specify if the XRT 400 is supplied sterile, but it is classified as a Class II device with special controls.

  • What are the regulatory controls for the XRT 400?

    The XRT 400 is subject to regulations, including 892.1980, and has a product code of KXJ, with FDA 510K authorizations.