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Collimator Light Source (IZT)

by Denar Corp. 510(k)

Active United States

510(k) K924759

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK924759 Date9 Dec 1992ClearedStatusActive

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  • Withdrawn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 6 Oct 2026.

Specification

510(k)

Full name
Collimator Light Source
510(k) Number
FDA Product Code
IZT
Device Class
Class II
Regulation
21 CFR Part 892.1610
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 Collimator Light Source (IZT) is a radiographic cone, classified under the FDA’s product code IZT, designed to focus and direct light during radiographic imaging procedures. It functions as an optical device to align and restrict the light beam, ensuring precise alignment with the X-ray beam for accurate fluoroscopic or radiographic imaging in radiology settings.

This device is supplied as a reusable component integrated into radiographic systems and is intended for use in controlled clinical environments. It is regulated under FDA’s 510(k) clearance (K924759) as a Class II medical device, adhering to the requirements of regulation number 892.1610. No specific sterility or single-use designation is noted in the regulatory data.

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