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Visualizer 2000

by Vf-Works, Inc.

510(k) K943272

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 NumberK943272 Date27 Dec 1994ClearedStatusActive

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  • Withdrawn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
JAA
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Visualizer 2000 is a System, X-Ray, Fluoroscopic, Image-Intensified device. It is a fluoroscopy system used in radiology.

The Visualizer 2000 is supplied with a product code of JAA and is regulated under regulation number 892.1650. It has been cleared under K-number K943272 and has an FDA 510K authorization. The device is manufactured by Vf-Works, Inc. and has a registration number.

Questions

AI-generated answers, 22 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 Visualizer 2000 used for?

    The Visualizer 2000 is used in radiology for fluoroscopy procedures, providing image-intensified X-ray capabilities.

  • What is the regulatory status of the Visualizer 2000?

    The Visualizer 2000 has been cleared under FDA 510K authorization, with a product code of JAA and regulated under regulation number 892.1650.

  • Who manufactures the Visualizer 2000?

    The Visualizer 2000 is manufactured by Vf-Works, Inc.

  • What is the device class of the Visualizer 2000?

    The Visualizer 2000 is classified as a Class 2 device, with a medical specialty description of Radiology.