510(k) Report

FDA applicant

Forte Automation Systems, Inc.

Machesney Park, IL2 decisions2012–20171 recall

FDA records 2 decisions for Forte Automation Systems, Inc. (Machesney Park, IL) from 2012 to 2017: 2 510(k) clearances. All are in product code JAI (Couch, Radiation Therapy, Powered). Its devices cite 1 predicate, 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 Forte Automation Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2012: 12017: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2012high 1 (2017) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Forte Automation Systems, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JAICouch, Radiation Therapy, Powered2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K122413Patient Positioning SystemForte Automation Systems, Inc. · 20121cites it

What has FDA decided for it lately?

  • K170502Patient Positioning SystemForte Automation Systems, Inc. · 2017
  • K122413Patient Positioning SystemForte Automation Systems, Inc. · 20121 recall

All 2 as Forte Automation Systems, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K122413Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10…Sep 5, 2017Class II