510(k) Report

FDA applicant

Sitco, Inc.

Mundelein, IL4 decisions1995–19990 recalls

FDA records 4 decisions for Sitco, Inc. (Mundelein, IL) from 1995 to 1999: 4 510(k) clearances. Most are in product codes IZH (System, X-Ray, Mammographic) and KPS (System, Tomography, Computed, Emission). Its devices cite 3 predicates, 0 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 Sitco, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sitco, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sitco, 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?

  • IZHSystem, X-Ray, Mammographic3decisions
  • KPSSystem, Tomography, Computed, Emission1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K953255Nuquest Nuclear Medicine ComputerSitco, Inc. · 19952cite it
  • K990192Biopsy-DigitSitco, Inc. · 19991cites it
  • K973856Giotto HTSitco, Inc. · 19971cites it

What has FDA decided for it lately?

  • K990192Biopsy-DigitSitco, Inc. · 1999
  • K982049Biopsy MSitco, Inc. · 1998
  • K973856Giotto HTSitco, Inc. · 1997
  • K953255Nuquest Nuclear Medicine ComputerSitco, Inc. · 1995

All 4 as Sitco, Inc. →