510(k) Report

FDA applicant

Ge Lunar Corp.

Madison, WI4 decisions1998–20033 recalls

FDA records 4 decisions for Ge Lunar Corp. (Madison, WI) from 1998 to 2003: 3 510(k) clearances and 1 original PMA approval. Most are in product codes KGI (Densitometer, Bone) and MUA (Bone Sonometer). Its devices cite 7 predicates, 0 of them its own earlier devices. 3 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 Lunar Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ge Lunar Corp. since 2007.

Recalls per year

2in 2019

2018: 12019: 2
2007high 2 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Ge Lunar Corp.’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, Bone3decisions
  • MUABone Sonometer1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 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.

  • K011917Advanced Hip Assessment SoftwareGe Lunar Corp. · 20015cite it
  • K023554Dual-Energy Vertebral Assessment View SoftwareGe Lunar Corp. · 20024cite it
  • P970040Achilles Express UltrasonometerGe Lunar Corp. · 19981cites it

What has FDA decided for it lately?

  • K030962DPX Series Bravo Duo Bone DensitometerGe Lunar Corp. · 20031 recall
  • K023554Dual-Energy Vertebral Assessment View SoftwareGe Lunar Corp. · 2002
  • K011917Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001
  • P970040Achilles Express UltrasonometerGe Lunar Corp. · 19982 recalls

All 4 as Ge Lunar Corp. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • P970040Achilles Insight Bone SonometerSep 3, 2019Class II
  • P970040Achilles Express Bone SonometerSep 3, 2019Class II
  • K030962GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number…Mar 16, 2018Class II