# K043134: Metrx Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Medical Metrx Solutions, Inc.
- Decided: Dec 13, 2004 after 31 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Vitrea 2: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K000852: Renew Neurostimulation System, Advanced Neuromodulation Systems (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Metrx Workstation is intended for users to segment and differentiate tissues and anatomical structures from two-dimensional imaging data, and to construct accurate, three-dimensional models from these segmented data. Metrx also provides the user with tools to better visualize and analyze the processed data. Metrx data may be outputted as the source data for Preview® Treatment Planning Software. The Metrx product is not intended to provide medical diagnosis or a recommended treatment approach.

Source page: https://510kreport.com/device/K043134
Methodology: https://510kreport.com/methodology