510(k) Report

FDA applicant

Ge Medical Systems Ultrasound and Primary

Wauwatosa, WI1 decision2018–20181 recall

FDA records 1 decision for Ge Medical Systems Ultrasound and Primary (Wauwatosa, WI) in 2018: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). 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 Medical Systems Ultrasound and Primary’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2018high 1 (2024) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Ge Medical Systems Ultrasound and Primary by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision

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.

  • K173456ViewPoint 6Ge Medical Systems Ultrasound and Primary · 20181cites it

What has FDA decided for it lately?

  • K173456ViewPoint 6Ge Medical Systems Ultrasound and Primary · 20181 recall

The one decision as Ge Medical Systems Ultrasound and Primary →

What has been recalled?

1 recall linked to its devices; the latest:

  • K103458ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e)…Aug 8, 2024Class II