Skip to content

Dexela Dex Top Mammography Workstation, Model Mamwkvi

by Dexela, Ltd.

510(k) K080351

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 NumberK080351 Date22 Apr 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  • Withdrawn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, 24 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 device is a system, image, designed to assist the radiologist in conducting screening and primary diagnosis through flexible, fast and efficient image hanging and processing of multimodality soft-copy images with special emphasis and optimization for mammography. It is a software product that runs on a high-end personal computer for the purpose of non-invasive multi-modality review, providing high-performance viewing, processing and analysis of multimodality two and three dimensional, as well as planar medical image data.

The device receives digital image data from various sources and is used in radiology settings. It was cleared by the FDA through the 510(k) process under K080351, with a traditional clearance type and substantially equivalent decision. The device is supplied as a software system requiring a compatible high-end personal computer for operation.

Questions

AI-generated answers, 24 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 DEX TOP MAMMOGRAPHY WORKSTATION used for?

    The DEX TOP MAMMOGRAPHY WORKSTATION is a software system designed to assist radiologists in conducting screening and primary diagnosis through flexible, fast and efficient image hanging and processing of multimodality soft-copy images, with special optimization for mammography.

  • What hardware is required to operate the DEX TOP MAMMOGRAPHY WORKSTATION?

    The device is supplied as a software system that requires a compatible high-end personal computer for operation. It receives digital image data from various sources and is used in radiology settings for non-invasive multi-modality review.

  • What regulatory approval does the DEX TOP MAMMOGRAPHY WORKSTATION have?

    The device was cleared by the FDA through the 510(k) process under K080351, with a traditional clearance type and substantially equivalent decision. This clearance indicates it meets the necessary regulatory requirements for use in medical imaging.

  • What types of images can be processed by the DEX TOP MAMMOGRAPHY WORKSTATION?

    The workstation provides high-performance viewing, processing and analysis of multimodality two and three dimensional, as well as planar medical image data, making it suitable for various imaging needs in radiology settings.