510(k) Report

FDA applicant

U-System, Inc.

San Jose, CA1 decision2008–20081 recall

FDA records 1 decision for U-System, Inc. (San Jose, CA) in 2008: 1 510(k) clearance. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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-System, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2008high 1 (2013) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — U-System, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like U-System, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K080930Modification to Automated Breast Ultrasound System, Model AbusU-System, Inc. · 20081cites it

What has FDA decided for it lately?

  • K080930Modification to Automated Breast Ultrasound System, Model AbusU-System, Inc. · 20081 recall

The one decision as U-System, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K080930Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated…May 16, 2013Class II