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Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)

by Vieworks Co., Ltd.

510(k) K221512

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221512↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK221512 Date20 Jul 2022ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

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

Overview

AI-generated summary, 18 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 Vivix-S FW is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed for high-resolution radiographic imaging. It converts X-ray exposure into digital signals, enabling real-time visualization for diagnostic radiology procedures. These imagers are engineered to provide precise, high-quality images for various medical applications, including fluoroscopy and general radiography.

The Vivix-S FW is supplied as a reusable medical device, intended for use in radiology departments and imaging centers. It is classified as Class II under FDA regulations and has received FDA 510K clearance, MDD, and MDR authorizations. The device is not MRI-safe and must be stored in a clean, controlled environment to maintain performance and sterility. Models include specific reference codes for compatibility with different imaging systems.

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Questions

AI-generated answers, 18 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 types of medical imaging procedures is the Vivix-S FW designed to support, and how does it improve image quality?

    The Vivix-S FW is a Solid State X-Ray Imager (Flat Panel/Digital Imager) specifically engineered for fluoroscopy and general radiography, enabling real-time digital visualization of high-resolution radiographic images. Its digital signal conversion enhances precision and clarity, making it suitable for diagnostic radiology procedures where detailed imaging is critical.

  • Is the Vivix-S FW intended for single-use or reusable applications, and what maintenance is required to ensure proper function?

    The Vivix-S FW is reusable, designed for use in radiology departments and imaging centers. Since it is not sterile by design, it must be cleaned and maintained in a controlled environment to preserve performance and sterility. Regular cleaning protocols are essential to prevent contamination and ensure reliable operation over repeated uses.

  • What models of the Vivix-S FW are available, and how do they differ in terms of compatibility or specifications?

    The Vivix-S FW comes in three models: FXRD-2530FAW, FXRD-3643FAW, and FXRD-4343FAW. These models are tailored for compatibility with different imaging systems, though exact technical differences (such as detector size or resolution) are not specified in the provided data. The models are all Class II devices and share the same core functionality as a Solid State X-Ray Imager for fluoroscopy and radiography.

  • What regulatory pathways has the Vivix-S FW undergone, and what does this mean for its use in clinical settings?

    The Vivix-S FW has received FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) authorizations. This indicates it has been evaluated for safety and performance under applicable regulations, allowing its use in clinical settings where these certifications are recognized. The device is classified as Class II under FDA regulations, reflecting its moderate risk level.

  • Can the Vivix-S FW be used in an MRI environment, and what storage conditions are recommended to maintain its performance?

    The Vivix-S FW is not MRI-safe, meaning it should never be used or stored in an MRI environment due to potential interference or safety risks. To maintain performance and sterility, it should be stored in a clean, controlled environment—specific conditions like temperature or humidity are not detailed, but proper handling is implied to prevent contamination or damage.