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Light Beam Collimator

by Dealers X-Ray Co., Inc. 510(k)

Active United States

510(k) K843244

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843244 Date14 Sep 1984ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 5 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IZW
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.

The Light Beam Collimator is an Automatic Radiographic Collimator, a Class II medical device designed to precisely control and shape the X-ray beam in radiographic imaging. It ensures accurate alignment and reduces unnecessary radiation exposure by limiting the field of view to the area of interest, thereby improving image quality and patient safety. This device is specifically categorized under the Radiographic Collimator nomenclature and is intended for use in radiology procedures.

This device is supplied as a reusable component integrated into radiographic imaging systems and is regulated under FDA 510(k) clearance (K843244) with a Traditional clearance pathway. It is classified under the Radiology advisory committee and adheres to regulatory standards outlined in 21 CFR 892.1610. The Light Beam Collimator is designed for use in controlled clinical environments, such as radiology departments, and requires proper maintenance to ensure continued functionality and safety.