510(k) Report

FDA applicant

Ge Medical Systems Israel

Tirat Hacarmel, IL2 decisions2014–20253 recalls

FDA records 2 decisions for Ge Medical Systems Israel (Tirat Hacarmel, IL) from 2014 to 2025: 2 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 5 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Ge Medical Systems Israel , Ltd.”.

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 Israel’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2014: 12025: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2024

2023: 22024: 1
2014high 2 (2023) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Ge Medical Systems Israel by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KPSSystem, Tomography, Computed, Emission1decision
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision

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 5 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.

  • K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd. · 20145cite it

What has FDA decided for it lately?

  • K251153AuroraGe Medical Systems Israel · 2025
  • K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd. · 20143 recalls

The one decision as Ge Medical Systems Israel →The one decision as Ge Medical Systems Israel, Ltd. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K142323GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SWMay 2, 2024Class II
  • K142323GE Healthcare Vivid S60, ultrasound deviceMay 30, 2023Class II
  • K142323GE Healthcare Vivid S70, ultrasound deviceMay 30, 2023Class II