510(k) Report

FDA applicant

Traxtal Technologies, Inc.

Toronto, Ontario, CA1 decision2006–20063 recalls

FDA records 1 decision for Traxtal Technologies, Inc. (Toronto, Ontario, CA) in 2006: 1 510(k) clearance. All are in product code JAK (System, X-Ray, Tomography, Computed). Its devices cite 38 predicates, 0 of them its own earlier devices. 3 recalls are 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 Traxtal Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Traxtal Technologies, Inc. since 2007.

Recalls per year

2in 2011

2010: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Traxtal Technologies, 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?

  • JAKSystem, X-Ray, Tomography, Computed1decision

Whose devices does it build on?

Its devices cite 38 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K053610AbarisTraxtal Technologies, Inc. · 20067cite it

What has FDA decided for it lately?

  • K053610AbarisTraxtal Technologies, Inc. · 20063 recalls

The one decision as Traxtal Technologies, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K053610The SIU (System Interface Unit) is a component in the Tool Connection Unit of the…Jun 1, 2011
  • K053610PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number…Apr 1, 2011
  • K053610The PercuNav MP008R-B Button Probe is designed to be used with Philips (formerly…Nov 10, 2010