510(k) Report

FDA applicant

Ge Medical Systems F.I. Haifa

Tirat Hacarmel, IL17 decisions1998–201351 recalls

FDA records 17 decisions for Ge Medical Systems F.I. Haifa (Tirat Hacarmel, IL) from 1998 to 2013: 17 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and LLZ (System, Image Processing, Radiological). Its devices cite 30 predicates, 12 of them its own earlier devices. 51 recalls are linked to its devices, 3 Class I.

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 F.I. Haifa’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2008: 22009: 12010: 12013: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2008: 92011: 12012: 32013: 4, 2 Class I2014: 92017: 22018: 52019: 32020: 42021: 12022: 1, 1 Class I2024: 82025: 1
2007high 9 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ge Medical Systems F.I. Haifa by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ge Medical Systems F.I. Haifa’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, Emission14decisions
  • LLZSystem, Image Processing, Radiological3decisions

Whose devices does it build on?

Its devices cite 30 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 40 times; 12 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.

  • K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 20136cite it
  • K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 19996cite it
  • K093982Xeleris 3 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 20105cite it
  • K003264QPS/BPGS/Moco Processing Applications for Entegra WorkstationGe Medical Systems F.I. Haifa · 20004cite it
  • K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 20024cite it
  • K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 20094cite it

What has FDA decided for it lately?

  • K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
  • K093982Xeleris 3 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 20101 recall
  • K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 20092 Class I recalls
  • K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa · 20081 recall
  • K080124Ventri 1.1Ge Medical Systems F.I. Haifa · 20082 recalls
  • K051855VentriGe Medical Systems F.I. Haifa · 20053 recalls
  • K043381Infinia LightspeedGe Medical Systems F.I. Haifa · 2004
  • K033874MyolightGe Medical Systems F.I. Haifa · 2003

All 17 as Ge Medical Systems F.I. Haifa →

What has been recalled?

51 recalls linked to its devices; the latest:

  • K022960Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine systemJun 20, 2025Class II
  • K093514GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2)…Dec 18, 2024Class II
  • K093514GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System…Dec 18, 2024Class II
  • K022960GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4)…Dec 18, 2024Class II
  • K093514GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2)…Dec 18, 2024Class II
  • K093514GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System…Dec 18, 2024Class II