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Xviewnet

by American Radiologist Network, Inc.

510(k) K080290

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 · Traditional NumberK080290 Date22 Feb 2008ClearedStatusActive

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  • Withdrawn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 Xviewnet is a Class II X-ray system, a display and analysis tool for radiology. It is used in radiology for displaying and analyzing X-ray images.

The Xviewnet is supplied as a software tool, and it has been cleared under FDA 510(k) with the K-number K080290 in 2008. It is intended as a display and analysis tool, and its regulatory status is documented with the FDA.

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 Xviewnet used for?

    The Xviewnet is used in radiology for displaying and analyzing X-ray images, serving as a display and analysis tool.

  • How is the Xviewnet supplied?

    The Xviewnet is supplied as a software tool, intended for use in radiology departments.

  • What is the regulatory status of the Xviewnet?

    The Xviewnet has been cleared under FDA 510(k) with the K-number K080290, documented with the FDA as substantially equivalent.