510(k) Report

FDA applicant

Tomographic Tech

San Leandro, CA1 decision1995–19950 recalls

FDA records 1 decision for Tomographic Tech (San Leandro, CA) in 1995: 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 Tomographic Tech’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tomographic Tech since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tomographic Tech 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.

  • K941322Echo-ScanTomographic Tech · 19951cites it

What has FDA decided for it lately?

  • K941322Echo-ScanTomographic Tech · 1995

The one decision as Tomographic Tech →