510(k) Report

FDA applicant

Traxyz Medical, Inc.

Westborough, MA1 decision2005–20050 recalls

FDA records 1 decision for Traxyz Medical, Inc. (Westborough, MA) in 2005: 1 510(k) clearance. All are in product code IZH (System, X-Ray, Mammographic). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Traxyz Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Traxyz Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Traxyz Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IZHSystem, X-Ray, Mammographic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K050663Traxyloc-1 SystemTraxyz Medical, Inc. · 2005

The one decision as Traxyz Medical, Inc. →