510(k) Report

FDA applicant

Ge Healthcare Information Technologies

Barrington, IL2 decisions2006–20223 recalls

FDA records 2 decisions for Ge Healthcare Information Technologies (Barrington, IL) from 2006 to 2022: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and DQK (Computer, Diagnostic, Programmable). Its devices cite 8 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Ge Healthcare Information Technologies, Inc.”.

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

FDA decisions per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2008: 22023: 1
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ge Healthcare Information Technologies 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, Radiological1decision
  • DQKComputer, Diagnostic, Programmable1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K213972Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL…Ge Healthcare Information Technologies, Inc. · 20221cites it

What has FDA decided for it lately?

  • K213972Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL…Ge Healthcare Information Technologies, Inc. · 20221 recall
  • K061372Centricity AW Suite OptionGe Healthcare Information Technologies · 20062 recalls

The one decision as Ge Healthcare Information Technologies →The one decision as Ge Healthcare Information Technologies, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K213972Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569…Aug 8, 2023Class II
  • K061372GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus…Jun 11, 2008
  • K061372GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000…May 9, 2008