510(k) Report

FDA applicant

U.C.G. Technologies, Ltd.

Haifa, IL2 decisions2003–20030 recalls

FDA records 2 decisions for U.C.G. Technologies, Ltd. (Haifa, IL) in 2003: 2 510(k) clearances. All are in product code KPS (System, Tomography, Computed, Emission). Its devices cite 1 predicate, 1 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.C.G. Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for U.C.G. Technologies, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — U.C.G. Technologies, Ltd. 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?

  • KPSSystem, Tomography, Computed, Emission2decisions

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K030870WBR, Model HRU.C.G. Technologies, Ltd. · 20031cites it
  • K031874Modification to WBR, Model HRU.C.G. Technologies, Ltd. · 20031cites it

What has FDA decided for it lately?

  • K031874Modification to WBR, Model HRU.C.G. Technologies, Ltd. · 2003
  • K030870WBR, Model HRU.C.G. Technologies, Ltd. · 2003

All 2 as U.C.G. Technologies, Ltd. →