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AXT 150M Manual Collimator (AXT 150M)

by Applied X-Ray Technologies, Inc.

510(k) K972966

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 NumberK972966 Date21 Aug 1997ClearedStatusActive

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  • Withdrawn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
IZX
Device Class
Class II
Regulation
21 CFR Part 892.1610
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

A manual collimator designed for integration into diagnostic x-ray systems. It mechanically restricts and shapes the x-ray beam to the area of clinical interest, reducing patient exposure to unnecessary radiation.

Operated by licensed MDs or RTs, the device is a Class 2 Radiology device with product code IZX, cleared through the FDA 510(k) Traditional pathway under K972966. It is supplied as a reusable component for use in radiographic imaging settings.

Other devices from Applied X-Ray Technologies, Inc.

Questions

AI-generated answers, 1 Oct 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 AXT 150M Manual Collimator used for?

    The AXT 150M Manual Collimator is designed to mechanically restrict and shape the x-ray beam to the area of clinical interest during diagnostic radiographic imaging, thereby reducing patient exposure to unnecessary radiation by limiting the beam to only the necessary anatomy.

  • How is the AXT 150M Manual Collimator supplied and is it reusable?

    The device is supplied as a reusable component intended for integration into diagnostic x-ray systems, meaning it is designed for multiple uses after proper cleaning and maintenance, not as a single-use disposable item.

  • Who is authorized to operate the AXT 150M Manual Collimator?

    The AXT 150M Manual Collimator is operated by licensed medical doctors (MDs) or radiologic technologists (RTs), as it requires professional training to correctly align and adjust the collimator blades for accurate beam restriction during radiographic procedures.

  • What regulatory pathway was used for the AXT 150M Manual Collimator?

    The AXT 150M Manual Collimator was cleared through the FDA 510(k) Traditional pathway under submission K972966, demonstrating substantial equivalence to a legally marketed predicate device.