510(k) Report

FDA applicant

Siemens Molecular Imaging, Ltd.

Hoffman Estates, IL2 decisions2004–20060 recalls

FDA records 2 decisions for Siemens Molecular Imaging, Ltd. (Hoffman Estates, IL) from 2004 to 2006: 2 510(k) clearances. All are in product code KPS (System, Tomography, Computed, Emission). Its devices cite 5 predicates, 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 Siemens Molecular Imaging, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Siemens Molecular Imaging, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Siemens Molecular Imaging, 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

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K042863SceniumSiemens Molecular Imaging, Ltd. · 20043cite it
  • K061545Scenium 1.1Siemens Molecular Imaging, Ltd. · 20061cites it

What has FDA decided for it lately?

  • K061545Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
  • K042863SceniumSiemens Molecular Imaging, Ltd. · 2004

All 2 as Siemens Molecular Imaging, Ltd. →