510(k) Report

FDA applicant

Ge Medical Systems Ultrasound And

Wauwatosa, WI5 decisions2020–20221 recall

FDA records 5 decisions for Ge Medical Systems Ultrasound And (Wauwatosa, WI) from 2020 to 2022: 5 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 122 days from receipt to decision, against 72 for FDA’s reviews in the same codes and years. Its devices cite 5 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, radiology panel, where it files most

How often FDA has decided Ge Medical Systems Ultrasound And’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2020: 42022: 1
2020high 4 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2020high 1 (2024) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Ge Medical Systems Ultrasound And by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ge Medical Systems Ultrasound And’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?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic4decisions
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 122 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 72 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And · 20202cite it
  • K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And · 20222cite it
  • K192917ViewPoint 6Ge Medical Systems Ultrasound And · 20201cites it
  • K200708Vivid iqGe Medical Systems Ultrasound And · 20201cites it
  • K200138Versana PremierGe Medical Systems Ultrasound And · 20201cites it

What has FDA decided for it lately?

  • K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And · 2022
  • K200708Vivid iqGe Medical Systems Ultrasound And · 2020
  • K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And · 2020
  • K200138Versana PremierGe Medical Systems Ultrasound And · 2020
  • K192917ViewPoint 6Ge Medical Systems Ultrasound And · 20201 recall

All 5 as Ge Medical Systems Ultrasound And →

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