510(k) · Cleared
ClearedTraxyloc-1 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Traxyz Medical, Inc. · IZH System, X-Ray, Mammographic
Cleared on Apr 8, 2005 as substantially equivalent to K954521 (American Mammographics, Inc., 1995) after a 24-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Apr 8, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K954521 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK954521 Mammospot PaddleAmerican Mammographics, Inc. · 1995
- This deviceK050663 Traxyloc-1 SystemTraxyz Medical, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954521 | Mammospot Paddle | American Mammographics, Inc. | 1995 | — |
| 0 (this device) | K050663 | Traxyloc-1 System | Traxyz Medical, Inc. | 2005 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IZH device
- #1 K202294 Affirm Contrast Biopsyscore 1.0 · 4 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K950981 | FDA’s K950981 is Ultra-Pro Ultrasound Scanning Table Model #056-650 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1995 |
| * | K954521 | Mammospot PaddleSummary page 1…opf Date Prepared: March 7, 2005 Name of Device: Traxyz Medical Inc. TraxyLocTM -1 System Predicate Device: Lorad Digital Spot Mammography KS09810 Mammospot Paddle K954521 Intended Use: The TraxyLocTM-1 System is a near-real time, image-guided accessory to mammography equipment designed to stabiliz… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All IZH devicesIZH System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZH
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · IZH
64in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZH
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZH
15in 2025
MAUDE reports naming product code IZH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 30 | 0 | 11 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 2 | — | 0 | 7 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 2 | — | 0 | 18 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 3 | 64 | 0 | 9 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 1 | — | 0 | 39 |
| 2020 | 1 | — | 0 | 7 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050663: Traxyloc-1 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050663
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026