510(k) Report

FDA applicant

Ge Healthcare Integrated IT Solutions

Barrington, IL4 decisions2006–20126 recalls

FDA records 4 decisions for Ge Healthcare Integrated IT Solutions (Barrington, IL) from 2006 to 2012: 4 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and HGM (System, Monitoring, Perinatal). Its devices cite 4 predicates, 0 of them its own earlier devices. 6 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 Healthcare Integrated IT Solutions’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2011: 22012: 1
2007high 2 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2025

2012: 12013: 12015: 12022: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ge Healthcare Integrated IT Solutions by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological3decisions
  • HGMSystem, Monitoring, Perinatal1decision

Whose devices does it build on?

Its devices cite 4 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.

  • K063628Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions · 20063cite it
  • K112570Centricity Cardio ImagingGe Healthcare Integrated IT Solutions · 20111cites it
  • K121387Centricity Pacs-IWGe Healthcare Integrated IT Solutions · 20121cites it

What has FDA decided for it lately?

  • K121387Centricity Pacs-IWGe Healthcare Integrated IT Solutions · 20121 recall
  • K112570Centricity Cardio ImagingGe Healthcare Integrated IT Solutions · 20111 recall
  • K111614Centricity Perinatal and Centricity Intensive CareGe Healthcare Integrated IT Solutions · 20111 recall
  • K063628Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions · 20063 recalls

All 4 as Ge Healthcare Integrated IT Solutions →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K042525GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2)…Feb 19, 2025Class II
  • K042525GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2)…Feb 19, 2025Class II
  • K042525Centricity Radiology RA600Apr 28, 2022Class II
  • K082318Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives…Sep 16, 2015Class II
  • K111614Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical…Mar 11, 2013Class II
  • K112570Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication…Oct 2, 2012Class II