Skip to content

Solid State X-ray Imager (Model: FXRD-4386WB)

by Vieworks Co., Ltd. South Korea 510(k)

510(k) K220239

Product code MQB

Overview

The Solid State X-ray Imager (Model: FXRD-4386WB) is a stationary diagnostic system designed to generate and control x-rays for examination of various anatomical regions. This device includes signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

The device is manufactured by Vieworks Co., Ltd. and received FDA 510(k) clearance on September 13, 2022, under number K220239. It is classified as a Solid State X-Ray Imager (Flat Panel/Digital Imager) with product code MQB and regulation number 892.1680. The device is intended for use in radiology applications.

Summary written by AI from registry data, 6 Oct 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK220239 Date13 Sep 2022ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
MQB
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Vieworks Co., Ltd.

See all devices from Vieworks Co., Ltd. →

Questions

  • What is the Solid State X-ray Imager FXRD-4386WB used for?

    The Solid State X-ray Imager (Model: FXRD-4386WB) is a stationary diagnostic system designed to generate and control x-rays for examination of various anatomical regions. It includes signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

  • What is the regulatory status of this device?

    The device received FDA 510(k) clearance on September 13, 2022, under number K220239. It is classified as a Solid State X-Ray Imager (Flat Panel/Digital Imager) with product code MQB and regulation number 892.1680.

  • Who manufactures the Solid State X-ray Imager FXRD-4386WB?

    The device is manufactured by Vieworks Co., Ltd., a company based in Anyang-Si, South Korea. The contact person for this device is Kevin Oh.

  • What advisory committee reviewed this device?

    The Solid State X-ray Imager was reviewed by the Radiology Advisory Committee (RA), which specializes in evaluating radiology devices. This indicates the device is intended for use in radiology applications.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K220239 24 fields · synced 22 Oct 2026