FDA applicant

U-Systems, Inc.

Los Altos,, CA6 decisions2001–20050 recalls

FDA records 6 decisions for U-Systems, Inc. (Los Altos,, CA) from 2001 to 2005: 6 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 4 predicates, 2 of them its own earlier devices. 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 U-Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for U-Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — U-Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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U-Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?