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Ultranet-S Collimator

by GE Medical Systems

510(k) K894142

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 NumberK894142 Date6 Nov 1989ClearedStatusActive

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  • Withdrawn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
IZW
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 Ultranet-S Collimator is an Automatic Radiographic Collimator, designed to precisely control and limit the size and shape of the X-ray beam in radiographic imaging procedures. It ensures optimal radiation exposure while improving image quality by reducing scatter and enhancing contrast, thereby supporting accurate diagnostic evaluations in radiology settings.

This device is intended for use in radiographic imaging systems and is supplied as a reusable component within a radiology department. It is classified under product code IZW and has received FDA 510(k) clearance (K894142) under the Radiology advisory committee, with a decision date of November 6, 1989. The device adheres to Class II regulatory standards and is intended for integration into radiographic imaging equipment as specified by the manufacturer.

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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 primary purpose of the ULTRANET-S Collimator in radiographic imaging?

    The ULTRANET-S Collimator is designed to precisely control and limit the size and shape of the X-ray beam during radiographic imaging. By doing so, it optimizes radiation exposure, reduces scatter radiation, and enhances image contrast, which helps improve the accuracy of diagnostic evaluations in radiology settings.

  • Is the ULTRANET-S Collimator intended for single-use or reusable applications?

    The ULTRANET-S Collimator is explicitly supplied as a reusable component within a radiology department. It is not intended for single-use and is meant to be integrated into radiographic imaging equipment for repeated use.

  • What regulatory pathway was followed for FDA clearance of the ULTRANET-S Collimator?

    The ULTRANET-S Collimator received FDA 510(k) clearance under the Traditional review pathway, with a decision date of November 6, 1989. It was determined to be substantially equivalent to a legally marketed predicate device and was reviewed by the Radiology Advisory Committee (RA). The clearance number assigned is K894142.

  • What types of radiographic imaging systems is the ULTRANET-S Collimator compatible with?

    The ULTRANET-S Collimator is designed for integration into radiographic imaging equipment as specified by the manufacturer. While the exact compatibility details are not provided, its classification under product code IZW (Automatic Radiographic Collimator) suggests it is intended for general radiographic systems used in radiology departments.

  • How many registration numbers are associated with the ULTRANET-S Collimator?

    The ULTRANET-S Collimator has multiple registration numbers listed, including 3010703925, 3030220356, 3023546785, and others. These numbers correspond to different models or variants of the device, as indicated by the associated FEI numbers and regulatory filings.