510(k) Report

FDA applicant

Ge Medical Systems Ultrasound & Primary Care Diagn

Madison, WI1 decision2014–20141 recall

FDA records 1 decision for Ge Medical Systems Ultrasound & Primary Care Diagn (Madison, WI) in 2014: 1 510(k) clearance. All are in product code KGI (Densitometer, Bone). Its devices cite 3 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, radiology panel, where it files most

How often FDA has decided Ge Medical Systems Ultrasound & Primary Care Diagn’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2014high 1 (2019) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Ge Medical Systems Ultrasound & Primary Care Diagn by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KGIDensitometer, Bone1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K133664Encore Version 16 Software for GE Lunar Dxa Bone DensitometersGe Medical Systems Ultrasound & Primary Care Diagn · 20141 recall

The one decision as Ge Medical Systems Ultrasound & Primary Care Diagn →

What has been recalled?

1 recall linked to its devices; the latest:

  • K133664Lunar iDXA Advance (iDXA with enCORE v16) bone densitometerDec 3, 2019Class II