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Metrx Workstation

FDA 510(k)

Class II (US FDA 510(k))

510(k) K043134

by Medical Metrx Solutions, Inc.

Identifiers

510(k) Number
K043134 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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.

Frequently asked questions

What is the primary purpose of the METRX WORKSTATION?

The METRX WORKSTATION is designed for radiological imaging and three-dimensional reconstruction of anatomical structures, integrating image processing capabilities to segment tissues and generate precise volumetric models from two-dimensional imaging data.

How is the METRX WORKSTATION supplied?

The device is supplied as a traditional Class II medical device that includes proprietary software for image analysis and treatment planning, though specific sterility or single-use/reusable status is not detailed in the regulatory filing.

What regulatory pathway was used for the METRX WORKSTATION?

The METRX WORKSTATION was cleared under the FDA's 510(k) pathway with clearance number K043134 issued in 2004, and it is regulated under product code LLZ (21 CFR 892.2050).

In what settings is the METRX WORKSTATION intended to be used?

The device is intended for use in radiology settings to support advanced diagnostic and treatment planning applications through its image processing and three-dimensional reconstruction capabilities.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Metrx Workstation - allmed.wiki, PDF r 3 Medical Metrx Solutions C. I ?[04 Traditional 510(k) Metrx ..., Metrx Workstation 510 (k) FDA Premarket Notification K043134 MEDICAL ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medical Metrx Solutions, Inc.

Sources (1)

  • FDA 510(k) K043134 24 fields · synced Sep 19, 2026