510(k) Report

FDA applicant

Ge Medical Syst. Information Technologies

Wauwatosa, WI2 decisions2004–20091 recall

FDA records 2 decisions for Ge Medical Syst. Information Technologies (Wauwatosa, WI) from 2004 to 2009: 2 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and DQK (Computer, Diagnostic, Programmable). Its devices cite 2 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, cardiovascular panel, where it files most

How often FDA has decided Ge Medical Syst. Information Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ge Medical Syst. Information Technologies by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ge Medical Syst. Information…’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?

  • DPSElectrocardiograph1decision
  • DQKComputer, Diagnostic, Programmable1decision

Whose devices does it build on?

Its devices cite 2 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.

  • K090212Mac 800 Resting Ecg Analysis SystemGe Medical Syst. Information Technologies · 20093cite it

What has FDA decided for it lately?

  • K090212Mac 800 Resting Ecg Analysis SystemGe Medical Syst. Information Technologies · 20091 recall
  • K042148Heart Rate Turbulence Analysis TechnologiesGe Medical Syst. Information Technologies · 2004

All 2 as Ge Medical Syst. Information Technologies →

What has been recalled?

1 recall linked to its devices; the latest:

  • K090212GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG…Dec 10, 2009