510(k) · Cleared

Cleared

GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile Kit

K072439510(k) SpecialCleared Sep 14, 200715-day reviewClass II21 CFR 892.1170

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 Sep 14, 2007 as substantially equivalent to K915535 (Lunar, 1992) and 7 other predicates after a 15-day review. Its family tree reaches back 3 generations to 1990.

Decided: Sep 14, 2007
Review: 15 days
Class: Class II
Product code: KGI
Recalls: None
Predicates: 8

Its longest line of descent runs back 3 generations to K890121 (1990). 16 ancestors in all, the oldest K884625 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK890121 Modified DPX Bone DensitometerLunar · 1990
2 generations backK961007 Expert Spine Morphotietry ReferenceLunar Corp. · 1996
1 generation backK011917 Advanced Hip Assessment SoftwareGe Lunar Corp. · 2001
This deviceK072439 GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile KitGe Medical Systems Ultrasound and Primary Care Dia · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K890121	Modified DPX Bone Densitometer	Lunar	1990	—
−2	K961007	Expert Spine Morphotietry Reference	Lunar Corp.	1996	—
−1	K011917	Advanced Hip Assessment Software	Ge Lunar Corp.	2001	—
0 (this device)	K072439	GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile Kit	Ge Medical Systems Ultrasound and Primary Care Dia	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1990	1	0
1992	1	0
1995	3	0
1998	2	0
1999	1	0
2000	3	0
2002	1	0

FIG. 1 — Lineage of K072439, 1990–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K252718 Lunar Astrascore 13.3 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K915535	Forearm Software for Lunar DPX Series Bone Desitom Summary page 1 …Prodigy Series DEXA Bone Densitometers with Mobile Kit, 21 CFR 892.1170, 90-KGI 3. Marketed Device: DPX and Prodigy series bone densitometers: K915535 K982267 K983564 K000826 K001756 K001812 K011917 K023554 currently in commercial distrib…	Lunar	1992	—
*	K982267	DPX-RX Bone Densitometer Summary page 1 …Series DEXA Bone Densitometers with Mobile Kit, 21 CFR 892.1170, 90-KGI 3. Marketed Device: DPX and Prodigy series bone densitometers: K915535 K982267 K983564 K000826 K001756 K001812 K011917 K023554 currently in commercial distribution. 4…	Lunar Corp.	1998	1
*	K983564	Prodigy Total Body Software Summary page 1 …DEXA Bone Densitometers with Mobile Kit, 21 CFR 892.1170, 90-KGI 3. Marketed Device: DPX and Prodigy series bone densitometers: K915535 K982267 K983564 K000826 K001756 K001812 K011917 K023554 currently in commercial distribution. 4. Device…	Lunar Corp.	1998	—
*	K000826	Prodigy Lateral View Software Summary page 1 …Mobile Kit, 21 CFR 892.1170, 90-KGI 3. Marketed Device: DPX and Prodigy series bone densitometers: K915535 K982267 K983564 K000826 K001756 K001812 K011917 K023554 currently in commercial distribution. 4. DeviceDescription: The GE Lunar DPX…	Lunar Corp.	2000	—
*	K001756	Lunar Report Generator II Summary page 1 …it, 21 CFR 892.1170, 90-KGI 3. Marketed Device: DPX and Prodigy series bone densitometers: K915535 K982267 K983564 K000826 K001756 K001812 K011917 K023554 currently in commercial distribution. 4. DeviceDescription: The GE Lunar DPX and Pro…	Lunar Corp.	2000	—
*	K001812	Pediatric Reference Data Summary page 1 …21 CFR 892.1170, 90-KGI 3. Marketed Device: DPX and Prodigy series bone densitometers: K915535 K982267 K983564 K000826 K001756 K001812 K011917 K023554 currently in commercial distribution. 4. DeviceDescription: The GE Lunar DPX and Prodigy Ser…	Lunar Corp.	2000	—
*	K011917	Advanced Hip Assessment Software Summary page 1 …21 CFR 892.1170, 90-KGI 3. Marketed Device: DPX and Prodigy series bone densitometers: K915535 K982267 K983564 K000826 K001756 K001812 K011917 K023554 currently in commercial distribution. 4. DeviceDescription: The GE Lunar DPX and Prodigy Series DEXA…	Ge Lunar Corp.	2001	—
*	K023554	Dual-Energy Vertebral Assessment View Software Summary page 1 …21 CFR 892.1170, 90-KGI 3. Marketed Device: DPX and Prodigy series bone densitometers: K915535 K982267 K983564 K000826 K001756 K001812 K011917 K023554 currently in commercial distribution. 4. DeviceDescription: The GE Lunar DPX and Prodigy Series DEXA Bone De…	Ge Lunar Corp.	2002	—

Also cleared against K915535: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
1 of the 16 ancestors has a recall of any class.
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. 2007, this device’s year, is highlighted.

FDA decisions per year · KGI

3in 2025

2007high 5 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGI

156in 2025

2007high 173 (2008) · low 142 (2012)2026

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

Recalls per year · KGI

1in 2016

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	5	173	6	2
2009	1	—	9	3
2010	0	—	0	0
2011	2	—	1	5
2012	5	142	0	1
2013	1	—	0	1
2014	2	—	0	2
2015	0	—	0	0
2016	2	—	1	1
2017	0	—	0	16
2018	1	—	0	6
2019	1	—	0	0
2020	0	—	0	2
2021	0	—	0	1
2022	2	—	0	1
2023	1	—	0	2
2024	0	—	0	2
2025	3	156	0	8
2026	2	—	0	—

What is it indicated for?

The GE Lunar DPX and Prodigy Series DEXA Bone Densitometers with Mobile Kit provide a measurement 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.

https://510kreport.com/device/K072439 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072439: GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072439

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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