510(k) Report

FDA applicant

Ge Healthcare Surgery

Salt Lake City, UT1 decision2009–20094 recalls

FDA records 1 decision for Ge Healthcare Surgery (Salt Lake City, UT) in 2009: 1 510(k) clearance. All are in product code OWB (Interventional Fluoroscopic X-Ray System). Its devices cite 2 predicates, 0 of them its own earlier devices. 4 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 Surgery’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2025

2014: 12023: 12024: 12025: 1
2009high 1 (2014) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Ge Healthcare Surgery by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OWBInterventional Fluoroscopic X-Ray System1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K082781Oec 9900 EliteGe Healthcare Surgery · 20093cite it

What has FDA decided for it lately?

  • K082781Oec 9900 EliteGe Healthcare Surgery · 20094 recalls

The one decision as Ge Healthcare Surgery →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K073543GE HealthCare OEC 9900 Elite C-arm Systems.Jul 2, 2025Class II
  • K120613OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite…Nov 21, 2024Class II
  • K073543OEC 9900 Systems with 9-inch Image IntensifierMay 15, 2023Class II
  • K061953The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is…Mar 31, 2014Class II