510(k) Report

FDA applicant

Georgene Austria

Woodland Hills, CA1 decision2006–20060 recalls

FDA records 1 decision for Georgene Austria (Woodland Hills, CA) in 2006: 1 510(k) clearance. All are in product code ITX (Transducer, Ultrasonic, Diagnostic). 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 Georgene Austria’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Georgene Austria since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Georgene Austria 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?

  • ITXTransducer, Ultrasonic, Diagnostic1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K053463Aim Accuracy in Marking SystemGeorgene Austria · 20061cites it

What has FDA decided for it lately?

  • K053463Aim Accuracy in Marking SystemGeorgene Austria · 2006

The one decision as Georgene Austria →