510(k) Report

FDA applicant

International Ultrasound Corp.

Englewood, NJ1 decision1997–19970 recalls

FDA records 1 decision for International Ultrasound Corp. (Englewood, NJ) in 1997: 1 510(k) clearance. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). 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 International Ultrasound Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for International Ultrasound Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — International Ultrasound Corp. 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?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

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.

  • K961229HR12000 Ultrasound SystemInternational Ultrasound Corp. · 19971cites it

What has FDA decided for it lately?

  • K961229HR12000 Ultrasound SystemInternational Ultrasound Corp. · 1997

The one decision as International Ultrasound Corp. →