510(k) Report

FDA applicant

General Electric Medical Systems Information Techn

Milwaukee, WI33 decisions1999–200212 recalls

FDA records 33 decisions for General Electric Medical Systems Information Techn (Milwaukee, WI) from 1999 to 2002: 33 510(k) clearances. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and DQK (Computer, Diagnostic, Programmable). Its devices cite 40 predicates, 9 of them its own earlier devices. 12 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, cardiovascular panel, where it files most

How often FDA has decided General Electric Medical Systems Information Techn’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for General Electric Medical Systems Information Techn since 2007.

Recalls per year

1in 2025

2008: 12013: 22018: 42019: 22025: 1
2007high 4 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — General Electric Medical Systems Information Techn by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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