510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Lunar Idxa

K052581510(k) SpecialCleared Oct 20, 200530-day reviewClass II21 CFR 892.1170Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ge Medical Systems Ultrasound and Primary Care Dia · KGI Densitometer, Bone

Cleared on Oct 20, 2005 as substantially equivalent to K915535 (Lunar, 1992) and 7 other predicates after a 30-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it. It has been recalled once.

Decided
Oct 20, 2005
Review
30 days
Class
Class II
Product code
KGI
Recalls
1
Predicates
8

Its longest line of descent runs back 3 generations to K890121 (1990). 16 ancestors in all, the oldest K884625 (1989). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 3 other ancestors1998: 2 other ancestors1992: 1 other ancestor1999: 1 other ancestor1995: 3 other ancestors1990: 1 other ancestor1989: 1 other ancestor2026: 1 descendant clearedK890121 · Modified DPX Bone Densitometer · Lunar · 1990K961007 · Expert Spine Morphotietry Reference · Lunar Corp. · 1996K011917 · Advanced Hip Assessment Software · Ge Lunar Corp. · 20011990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 6 other ancestors 1 generation forward: 1 descendant K011917 · Advanced Hip Assessment Software · Ge Lunar Corp. · 2001K961007 · Expert Spine Morphotietry Reference · Lunar Corp. · 1996K890121 · Modified DPX Bone Densitometer · Lunar · 19900
  1. Root · 3 generations backK890121 Modified DPX Bone DensitometerLunar · 1990
  2. 2 generations backK961007 Expert Spine Morphotietry ReferenceLunar Corp. · 1996
  3. 1 generation backK011917 Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001
  4. This deviceK052581 Lunar IdxaGe Medical Systems Ultrasound and Primary Care Dia · 2005
  5. Descendant · cites it directly · 0 of its ownK252718 Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K890121Modified DPX Bone DensitometerLunar1990—
−2K961007Expert Spine Morphotietry ReferenceLunar Corp.1996—
−1K011917Advanced Hip Assessment SoftwareGe Lunar Corp.2001—
0 (this device)K052581Lunar IdxaGe Medical Systems Ultrasound and Primary Care Dia2005—
+1K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199010
199210
199530
199820
199910
200030
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K052581, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KGI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KGI device

  1. #1 K252718 Lunar Astrascore 13.3 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K915535Forearm Software for Lunar DPX Series Bone Desitom
Summary page 1
…pared: September 191h , 2005 2. Device Name: Lunar DMA bone densitometer Bone Densitometer, ?1 CFR 89241170. 90-KGI 3. Marketed Device: Prodigy bone densitometer: K915535 K982267 K983564 [K000826 [K001756 [K001812 [K011917 [K023554 currently in commercial distribution. 4. Device…
Lunar1992—
*K982267DPX-RX Bone Densitometer
Summary page 1
…eptember 191h , 2005 2. Device Name: Lunar DMA bone densitometer Bone Densitometer, ?1 CFR 89241170. 90-KGI 3. Marketed Device: Prodigy bone densitometer: K915535 K982267 K983564 [K000826 [K001756 [K001812 [K011917 [K023554 currently in commercial distribution. 4. Device Descript…
Lunar Corp.19981
*K983564Prodigy Total Body Software
Summary page 1
…191h , 2005 2. Device Name: Lunar DMA bone densitometer Bone Densitometer, ?1 CFR 89241170. 90-KGI 3. Marketed Device: Prodigy bone densitometer: K915535 K982267 K983564 [K000826 [K001756 [K001812 [K011917 [K023554 currently in commercial distribution. 4. Device Description: The…
Lunar Corp.1998—
*K000826Prodigy Lateral View Software
Summary page 1
…005 2. Device Name: Lunar DMA bone densitometer Bone Densitometer, ?1 CFR 89241170. 90-KGI 3. Marketed Device: Prodigy bone densitometer: K915535 K982267 K983564 [K000826 [K001756 [K001812 [K011917 [K023554 currently in commercial distribution. 4. Device Description: The Lunar iD…
Lunar Corp.2000—
*K001756Lunar Report Generator II
Summary page 1
…Device Name: Lunar DMA bone densitometer Bone Densitometer, ?1 CFR 89241170. 90-KGI 3. Marketed Device: Prodigy bone densitometer: K915535 K982267 K983564 [K000826 [K001756 [K001812 [K011917 [K023554 currently in commercial distribution. 4. Device Description: The Lunar iDXA hone d…
Lunar Corp.2000—
*K001812Pediatric Reference Data
Summary page 1
…ne densitometer Bone Densitometer, ?1 CFR 89241170. 90-KGI 3. Marketed Device: Prodigy bone densitometer: K915535 K982267 K983564 [K000826 [K001756 [K001812 [K011917 [K023554 currently in commercial distribution. 4. Device Description: The Lunar iDXA hone densitometer is a full feature…
Lunar Corp.2000—
*K011917Advanced Hip Assessment Software
Summary page 1
…ometer Bone Densitometer, ?1 CFR 89241170. 90-KGI 3. Marketed Device: Prodigy bone densitometer: K915535 K982267 K983564 [K000826 [K001756 [K001812 [K011917 [K023554 currently in commercial distribution. 4. Device Description: The Lunar iDXA hone densitometer is a full featured general…
Ge Lunar Corp.2001—
*K023554Dual-Energy Vertebral Assessment View Software
Summary page 1
…ne Densitometer, ?1 CFR 89241170. 90-KGI 3. Marketed Device: Prodigy bone densitometer: K915535 K982267 K983564 [K000826 [K001756 [K001812 [K011917 [K023554 currently in commercial distribution. 4. Device Description: The Lunar iDXA hone densitometer is a full featured general purpose…
Ge Lunar Corp.2002—

Also cleared against K915535: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 3, 2019Class IIZ-1709-2020Radiation Control for Health and Safety ActAn issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
  • 1 of the 16 ancestors has a recall of any class.
  • Of its descendants, K252718 (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, 2026) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K915535.

How does its category compare?

All KGI devices

KGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGI

3in 2025

2007: 22008: 52009: 12011: 22012: 52013: 12014: 22016: 22018: 12019: 12022: 22023: 12025: 32026 (partial year): 2
2007high 5 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGI

156in 2025

2008: 173 days median2012: 142 days median2025: 156 days median
2007high 173 (2008) · low 142 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KGI

1in 2016

2008: 62009: 92011: 12016: 1
2007high 9 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KGI

8in 2025

2008: 22009: 32011: 52012: 12013: 12014: 22016: 12017: 162018: 62020: 22021: 12022: 12023: 22024: 22025: 8
2007high 16 (2017) · low 0 (2007)2025

MAUDE reports naming product code KGI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
2008517362
20091—93
20100—00
20112—15
2012514201
20131—01
20142—02
20150—00
20162—11
20170—016
20181—06
20191—00
20200—02
20210—01
20222—01
20231—02
20240—02
2025315608
20262—0—

What is it indicated for?

The Lunar iDXA Bone Densitometer provides an estimate of bone mineral density and fat and lean tissue mass. The values can then be compared to a reference population at the sole discretion of the physician.

Indications for use as stated in the FDA summary.

Also cleared against K915535

2 other devices cite the same predicate.

  • K072439GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile KitGe Medical Systems Ultrasound and Primary Care Dia · 2007
  • K964263Expert-KL and Hand Acquisition and Analysis SoftwareLunar Corp. · 1996

More from Ge Medical Systems Ultrasound and…

7 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in KGI

The KGI category page

  • K254072BoneVueCurvebeam AI / Curvebeam, LLC · 2026
  • K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
  • K2510223D-Shaper3D-Shaper Medical S.L · 2025
  • K242295BunkerHill BMDBunkerHill Health · 2025
  • K243218TBS iNsight (V4)Medimaps Group SA · 2025

https://510kreport.com/device/K052581 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052581: Lunar Idxa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052581

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026