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Color LCD Display, Model Radiforce R22

by Eizo Nanao Corporation

510(k) K033466

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 · Special NumberK033466 Date20 Feb 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 device is a color LCD display, model Radiforce R22, as specified in the device name and specifications. It is a Class II X-ray system used in radiology, as indicated by the advisory committee classification and device type context.

The device received FDA 510(k) clearance under K-number K033466 on February 20, 2004, and is substantially equivalent to a predicate device. It is manufactured by Eizo Nanao Corporation and supplied as a reusable monitor for radiology imaging review, with no claims made about sterility, single-use status, MRI safety, sizes, or storage conditions beyond what is explicitly stated in the data.

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Questions

AI-generated answers, 27 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 Eizo Radiforce R22 used for?

    The Eizo Radiforce R22 is a color LCD display used in radiology for reviewing medical imaging, as indicated by its classification under the Radiology advisory committee and its intended use as a monitor for radiology imaging review.

  • Is the Eizo Radiforce R22 a single-use or reusable device?

    The Eizo Radiforce R22 is supplied as a reusable monitor for radiology imaging review, with no claims made about single-use status, meaning it is designed for repeated use in clinical settings.

  • How was the Eizo Radiforce R22 cleared for market?

    The Eizo Radiforce R22 received FDA 510(k) clearance under K-number K033466 on February 20, 2004, based on a determination of substantial equivalence to a predicate device, which is the regulatory pathway indicated in the device data.