510(k) Report

FDA applicant

3D Ultrasound, Inc.

Durham, NC2 decisions1995–19970 recalls

FDA records 2 decisions for 3D Ultrasound, Inc. (Durham, NC) from 1995 to 1997: 2 510(k) clearances. 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 3D Ultrasound, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for 3D Ultrasound, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — 3D Ultrasound, 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?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic2decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • K952551Janus I3D Ultrasound, Inc. · 19951cites it
  • K963863Janus I3D Ultrasound, Inc. · 19971cites it

What has FDA decided for it lately?

  • K963863Janus I3D Ultrasound, Inc. · 1997
  • K952551Janus I3D Ultrasound, Inc. · 1995

All 2 as 3D Ultrasound, Inc. →