510(k) Report

FDA applicant

Ge Medical Systems Israel, Functional Imaging

Tirat Hacarmel, IL4 decisions2010–20251 recall

FDA records 4 decisions for Ge Medical Systems Israel, Functional Imaging (Tirat Hacarmel, IL) from 2010 to 2025: 4 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and IYX (Camera, Scintillation (Gamma)). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 65 for FDA’s reviews in the same codes and years. Its devices cite 6 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 Israel, Functional Imaging’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2010: 12024: 12025: 2
2010high 2 (2025) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2010high 1 (2025) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Ge Medical Systems Israel, Functional Imaging by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ge Medical Systems Israel, Functional…’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?

  • KPSSystem, Tomography, Computed, Emission2decisions
  • IYXCamera, Scintillation (Gamma)1decision
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 59 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 65 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 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.

  • K102231Discovery NM 750BGe Medical Systems Israel, Functional Imaging · 20102cite it
  • K243605AuroraGe Medical Systems Israel, Functional Imaging · 20251cites it

What has FDA decided for it lately?

  • K243605AuroraGe Medical Systems Israel, Functional Imaging · 2025
  • K241350Clarify DLGe Medical Systems Israel, Functional Imaging · 2025
  • K241665Omni LegendGe Medical Systems Israel, Functional Imaging · 20241 recall
  • K102231Discovery NM 750BGe Medical Systems Israel, Functional Imaging · 2010

All 4 as Ge Medical Systems Israel, Functional Imaging →

What has been recalled?

1 recall linked to its devices; the latest:

  • K221932GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend…Dec 24, 2025Class II