510(k) Report

FDA applicant

Ge Healthcare (Ge Medical Systems, LLC)

Waukesha, WI6 decisions2013–202246 recalls

FDA records 6 decisions for Ge Healthcare (Ge Medical Systems, LLC) (Waukesha, WI) from 2013 to 2022: 6 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 121 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 1 of them its own earlier devices. 46 recalls are 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, LLC)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2013: 22015: 12020: 22022: 1
2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2026

2015: 32016: 22017: 62021: 152022: 12024: 112025: 72026 (partial year): 1
2013high 15 (2021) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Ge Healthcare (Ge Medical Systems, LLC) by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LNHSystem, Nuclear Magnetic Resonance Imaging6decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 59 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 121 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 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.

  • K193282SIGNA PremierGe Healthcare (Ge Medical Systems, LLC) · 20205cite it
  • K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC) · 20152cite it
  • K132376Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC) · 20132cite it
  • K213668SIGNA HeroGe Healthcare (Ge Medical Systems, LLC) · 20222cite it
  • K123522Optima MR450WGe Healthcare (Ge Medical Systems, LLC) · 20131cites it

What has FDA decided for it lately?

  • K213668SIGNA HeroGe Healthcare (Ge Medical Systems, LLC) · 20222 recalls
  • K202966SIGNA ArchitectGe Healthcare (Ge Medical Systems, LLC) · 20208 recalls
  • K193282SIGNA PremierGe Healthcare (Ge Medical Systems, LLC) · 20207 recalls
  • K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC) · 201514 recalls
  • K132376Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC) · 201315 recalls
  • K123522Optima MR450WGe Healthcare (Ge Medical Systems, LLC) · 20131 recall

All 6 as Ge Healthcare (Ge Medical Systems, LLC) →

What has been recalled?

46 recalls linked to its devices; the latest:

  • K171128SIGNA Premier systemsFeb 27, 2026Class II
  • K171128GE SIGNA Premier, Nuclear Magnetic Resonance Imaging SystemJun 20, 2025Class II
  • K132376GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging SystemJun 20, 2025Class II
  • K160618GE SIGNA Architect, Nuclear Magnetic Resonance Imaging SystemJun 20, 2025Class II
  • K213668GE SIGNA Hero, Nuclear Magnetic Resonance Imaging SystemJun 20, 2025Class II
  • K160618SIGNA ArchitectMay 23, 2025Class II