510(k) Report

FDA applicant

Ge Medical Sysyems Ultrasound & Primary Care Diagn

Wauwatosa, WI1 decision2014–20140 recalls

FDA records 1 decision for Ge Medical Sysyems Ultrasound & Primary Care Diagn (Wauwatosa, WI) in 2014: 1 510(k) clearance. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 2 predicates, 0 of them its own earlier devices. No 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 Sysyems Ultrasound & Primary Care Diagn’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Ge Medical Sysyems Ultrasound & Primary Care Diagn by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ge Medical Sysyems Ultrasound &…’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, Ultrasonic1decision

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.

  • K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn · 20143cite it

What has FDA decided for it lately?

  • K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn · 2014

The one decision as Ge Medical Sysyems Ultrasound & Primary Care Diagn →