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Metrx Workstation

by Medical Metrx Solutions, Inc.

510(k) K043134

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK043134 Date13 Dec 2004ClearedStatusActive

Official records

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  • Withdrawn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, 19 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 Metrx Workstation is a Class II X-ray system designed for radiological imaging and three-dimensional reconstruction of anatomical structures. It integrates image processing capabilities to segment tissues and generate precise volumetric models from two-dimensional imaging data, supporting advanced diagnostic and treatment planning applications in radiology.

This device is supplied as a traditional Class II medical device cleared under the FDA’s 510(k) pathway, with clearance number K043134 issued in 2004. It is intended for use in radiology settings and is regulated under the product code LLZ (21 CFR 892.2050). The system includes proprietary software for image analysis and treatment planning, though specific sterility or single-use/reusable status is not detailed in the regulatory filing.

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).