510(k) Report

FDA applicant

Ge Healthcare (Ge Medical Systems Scs)

Waukesha, WI2 decisions2011–20121 recall

FDA records 2 decisions for Ge Healthcare (Ge Medical Systems Scs) (Waukesha, WI) from 2011 to 2012: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 3 predicates, 1 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 Ge Healthcare (Ge Medical Systems Scs)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2011: 12012: 1
2011high 1 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2011high 1 (2012) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Ge Healthcare (Ge Medical Systems Scs) by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ge Healthcare (Ge Medical Systems Scs)’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?

  • LLZSystem, Image Processing, Radiological2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K110573Ready ViewGe Healthcare (Ge Medical Systems Scs) · 20113cite it
  • K113456Ready ViewGe Healthcare (Ge Medical Systems Scs) · 20122cite it

What has FDA decided for it lately?

  • K113456Ready ViewGe Healthcare (Ge Medical Systems Scs) · 2012
  • K110573Ready ViewGe Healthcare (Ge Medical Systems Scs) · 20111 recall

All 2 as Ge Healthcare (Ge Medical Systems Scs) →

What has been recalled?

1 recall linked to its devices; the latest:

  • K110573GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.Mar 27, 2012Class II