510(k) Report

FDA applicant

Ge Medical System Ultrasound and Primary Care Diagnostics

Wauwatosa, WI1 decision2023–20232 recalls

FDA records 1 decision for Ge Medical System Ultrasound and Primary Care Diagnostics (Wauwatosa, WI) in 2023: 1 510(k) clearance. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 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 Medical System Ultrasound and Primary Care Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

2in 2023

2023: 2
2023high 2 (2023) · low 0 (2024)2026

Class I Class II/III not classified

FIG. 1 — Ge Medical System Ultrasound and Primary Care Diagnostics by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics · 20231cites it

What has FDA decided for it lately?

  • K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics · 20232 recalls

The one decision as Ge Medical System Ultrasound and Primary Care Diagnostics →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K182450GE Healthcare Vivid S70N, ultrasound deviceMay 30, 2023Class II
  • K182450GE Healthcare Vivid S60N, ultrasound deviceMay 30, 2023Class II