510(k) Report

FDA applicant

Ge Healthcare Technologies

Lawrence, MA2 decisions2004–20051 recall

FDA records 2 decisions for Ge Healthcare Technologies (Lawrence, MA) from 2004 to 2005: 2 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and IZL (System, X-Ray, Mobile). Its devices cite 4 predicates, 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, neurology panel, where it files most

How often FDA has decided Ge Healthcare Technologies’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ge Healthcare Technologies since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HAWNeurological Stereotaxic Instrument1decision
  • IZLSystem, X-Ray, Mobile1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K051734GE Healthcare Insta Trak 3500PLUS/ Fluoro Trak 9800 Plus System with Axcess Bone Pin, Model Part # 1006955Ge Healthcare Technologies · 20051 recall
  • K042866AMX5 and AMX5D Mobile X-Ray SystemsGe Healthcare Technologies · 2004

All 2 as Ge Healthcare Technologies →

What has been recalled?

1 recall linked to its devices; the latest:

  • K051734The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a…Nov 8, 2006Class II