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ViZion DR Wireless

by Viztek, LLC 510(k)

Active United States

510(k) K160810

Overview

The ViZion DR Wireless is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed for digital radiographic imaging. It captures high-resolution X-ray images using a wireless flat-panel detector, replacing traditional screen-film systems in general radiography while excluding fluoroscopy and angiography.

This device is intended for use in radiology settings and is supplied as a reusable system. It operates within MRI-safe parameters for the specified environments and is cleared under FDA 510(k) (K160810) as substantially equivalent to a predicate device. Multiple model variants are supported, as indicated by the listed registration numbers.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160810 Date20 May 2016ClearedStatusActive

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 AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

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

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Questions

  • What is the ViZion DR + Wireless intended for?

    The ViZion DR + Wireless is a Solid State X-Ray Imager (Flat Panel/Digital Imager) designed for digital radiographic imaging in radiology settings, capturing high-resolution X-ray images using a wireless flat-panel detector to replace traditional screen-film systems, excluding fluoroscopy and angiography.

  • How is the ViZion DR + Wireless supplied and is it reusable?

    The device is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and maintenance, not as a single-use disposable product.

  • What regulatory pathway was used for the ViZion DR + Wireless?

    The ViZion DR + Wireless was cleared under FDA 510(k) (K160810) as substantially equivalent to a predicate device, with a traditional clearance type and decision code SESE.

  • Are there multiple models or variants of the ViZion DR + Wireless?

    Yes, multiple model variants are supported, as indicated by the extensive list of registration numbers associated with the device, reflecting different configurations or versions within the product line.

  • In what type of environment can the ViZion DR + Wireless be used safely?

    The device operates within MRI-safe parameters for the specified environments, allowing use in settings where MRI compatibility is required, though specific environmental limits are not detailed in the provided data.