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Whis-Rad Tubstand Structure/Mobile Patient Trolley

by Bennett X-Ray Corp.

510(k) K935649

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK935649 Date9 Feb 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
KPR
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

This device is a System, X-Ray, Stationary, as defined in the device data. It is a mobile patient trolley with a tubstand structure designed for use in radiology settings.

It is supplied as a reusable device and has received FDA 510(k) clearance under K935649, with a decision date of February 9, 1994. The device is classified as Class II and is intended for use in radiology, as indicated by the advisory committee and medical specialty description.

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Questions

AI-generated answers, 28 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 WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY used for?

    This device is a mobile patient trolley with a tubstand structure designed specifically for use in radiology settings. It functions as a System, X-Ray, Stationary device to support patient positioning during radiological procedures.

  • Is the WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY a single-use or reusable device?

    The WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY is supplied as a reusable device. It is designed for multiple uses in radiology settings rather than being disposable after a single application.

  • What regulatory approvals does the WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY have?

    This device has received FDA 510(k) clearance under K935649 with a decision date of February 9, 1994. It is classified as Class II and is intended for use in radiology, as indicated by the advisory committee and medical specialty description.

  • What are the specifications of the WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY?

    The device is a mobile patient trolley with a tubstand structure designed for radiology settings. It is a reusable device that has been cleared as substantially equivalent under FDA 510(k) K935649. The device is classified as Class II and intended for radiology use.