510(k) Report

FDA applicant

Ge Medical Systems Ultrasound and Primary Care Dia

Madison, WI7 decisions2004–20112 recalls

FDA records 7 decisions for Ge Medical Systems Ultrasound and Primary Care Dia (Madison, WI) from 2004 to 2011: 7 510(k) clearances. Most are in product codes KGI (Densitometer, Bone) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 26 predicates, 2 of them its own earlier devices. 2 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 Medical Systems Ultrasound and Primary Care Dia’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 22008: 22011: 1
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2019

2018: 12019: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ge Medical Systems Ultrasound and Primary Care Dia by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ge Medical Systems Ultrasound and…’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?

  • KGIDensitometer, Bone4decisions
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 26 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 2 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.

  • K082185GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Ge Medical Systems Ultrasound and Primary Care Dia · 20088cite it
  • K041813GE Logiq 7 Ultrasound BT04Ge Medical Systems Ultrasound and Primary Care Dia · 20042cite it
  • K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 20082cite it
  • K052581Lunar IdxaGe Medical Systems Ultrasound and Primary Care Dia · 20051cites it
  • K103730GE Lunar Visceral Fat SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 20111cites it
  • K073408GE Logiq BT08 Diagnostic Ultrasound SystemGe Medical Systems Ultrasound and Primary Care Dia · 20071cites it

What has FDA decided for it lately?

  • K103730GE Lunar Visceral Fat SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2011
  • K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008
  • K082185GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Ge Medical Systems Ultrasound and Primary Care Dia · 20081 recall
  • K073408GE Logiq BT08 Diagnostic Ultrasound SystemGe Medical Systems Ultrasound and Primary Care Dia · 2007
  • K072439GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile KitGe Medical Systems Ultrasound and Primary Care Dia · 2007
  • K052581Lunar IdxaGe Medical Systems Ultrasound and Primary Care Dia · 20051 recall
  • K041813GE Logiq 7 Ultrasound BT04Ge Medical Systems Ultrasound and Primary Care Dia · 2004

All 7 as Ge Medical Systems Ultrasound and Primary Care Dia →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K052581Lunar iDXA bone densitometerDec 3, 2019Class II
  • K082185GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a…Mar 22, 2018Class II