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Thorax FD and Multix FD

by Siemens Medical Solutions USA, Inc.

510(k) K983732

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK983732 Date21 Apr 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1795-2013 FDA Class II initiated 5 Jun 2013

    Siemens issued a Field Safety Notice about the potential hazard to patients or operators when using the function "table top float" of the AXIOM Aristos MX. When repositioning a patient lying on the table top and releasing the table top, it is possible that the fingers of the patient or operator are between the table top and the detector tray and if the table top is moved, the fingers can be squee

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  • Withdrawn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
MQB
Device class
Class II
Regulation
21 CFR Part 892.1680
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 Thorax FD and Multix FD are solid state X-ray imagers, classified as flat panel or digital imagers. These systems allow for the acquisition of X-ray exposures without the use of conventional film or screen systems.

These devices are authorized under FDA 510(k) clearance. They are intended for use in radiology settings as part of radiography systems.

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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 are the Thorax FD and Multix FD systems used for?

    These devices are solid state X-ray imagers intended for use in radiology settings as a component of radiography systems. They function to acquire X-ray exposures for diagnostic imaging purposes.

  • How do these systems differ from traditional X-ray equipment?

    The Thorax FD and Multix FD are digital flat panel imagers. Unlike traditional systems, they allow for the acquisition of X-ray exposures without the requirement for conventional film or screen systems.

  • What is the regulatory status of these devices?

    The Thorax FD and Multix FD are authorized under FDA 510(k) clearance. This indicates that the devices have been reviewed and cleared for market as substantially equivalent to existing legally marketed predicate devices.