# K050663: Traxyloc-1 System

- Pathway: 510(k) (Traditional)
- Applicant: Traxyz Medical, Inc.
- Decided: Apr 8, 2005 after 24 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954521 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954521: Mammospot Paddle, American Mammographics, Inc. (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K950981: Ultra-Pro Ultrasound Scanning Table Model #056-650, Biodex Medical Systems, Inc. (1995). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The TraxyLocTM-1 System is a near-real time, image-guided accessory to mammography equipment designed to stabilize a patient's breast and assist a qualified physician in performing a pre-surgical, stereotactic needle localization procedure to target one or more mammographically previously discovered abnormalities for subsequent biopsy or other procedures.

Source page: https://510kreport.com/device/K050663
Methodology: https://510kreport.com/methodology