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Altairex Bucky/Cassette Tray Combination

by Altairex Manufacturing, Inc.

510(k) K873849

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 NumberK873849 Date28 Oct 1987ClearedStatusActive

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  • Withdrawn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
IXQ
Device Class
Class II
Regulation
21 CFR Part 892.1980
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Altairex Bucky/Cassette Tray Combination is a Radiographic Table, Stationary Top (per OpenFDA nomenclature), designed for use in radiology imaging. It integrates a Bucky tray—a grid device that reduces scatter radiation—and a cassette holder to support radiographic film or digital detectors during X-ray procedures. This combination ensures precise alignment and optimal image quality for diagnostic imaging.

This device is supplied as a reusable component for stationary radiographic tables and is intended for use in radiology departments. It adheres to FDA 510(k) clearance (K873849) under Regulation 892.1980, classified as a Class II medical device. The product code IXQ identifies its regulatory filing, and it was determined Substantially Equivalent (SESE) in 1987. No MRI safety or sterility requirements are specified in the data.

Questions

AI-generated answers, 19 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 purpose of the Altairex Bucky/Cassette Tray Combination?

    The device integrates a Bucky tray to reduce scatter radiation and a cassette holder to support radiographic film or digital detectors during X-ray procedures, ensuring precise alignment and optimal image quality for diagnostic imaging in radiology departments.

  • Is the Altairex Bucky/Cassette Tray Combination a single-use or reusable device?

    This device is supplied as a reusable component for stationary radiographic tables, designed for repeated use in radiology imaging procedures.

  • What regulatory status does the Altairex Bucky/Cassette Tray Combination have?

    The device has FDA 510(k) clearance (K873849) under Regulation 892.1980, classified as a Class II medical device, and was determined Substantially Equivalent (SESE) in 1987.

  • Are there any specific MRI safety or sterility requirements for this device?

    No MRI safety or sterility requirements are specified in the device data, indicating these aspects are not part of its regulatory specifications.