510(k) · Cleared
ClearedGE Lunar Body Composition Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Lunar · KGI Densitometer, Bone
Cleared on Jun 27, 2007 as substantially equivalent to K973459 (Norland Corp., 1998) after a 19-day review. Its family tree reaches back 2 generations to 1995. 10 later devices descend from it.
- Decided
- Jun 27, 2007
- Review
- 19 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935454 (1995). 10 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK935454 DPX Tissue Quantification OutputLunar Corp. · 1995
- 1 generation backK973459 Norland Body Composition Option for Norland Dexa Bone DensitometersNorland Corp. · 1998
- This deviceK071570 GE Lunar Body Composition SoftwareGe Medical Systems Lunar · 2007
- Descendant · cites it directly · 5 of its ownK113286 Encore 14 Software Release for the GE Lunar Dxa Bone DensitometersGe Medical Systems Lunar · 2012
- Descendant · cites it directly · 4 of its ownK161682 GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK191112 GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK103730 GE Lunar Visceral Fat SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2011
- Descendant · cites it directly · 1 of its ownK103265 Nhanes Whole Body Dxa Reference DatabaseHologic, Inc. · 2011
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K113286Encore 14 Software Release for the GE Lunar Dxa Bone DensitometersGe Medical Systems Lunar · 2012 · cites it directly5descendants
- K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · cites it directly4descendants
- K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · 2 generations on2descendants
- K103730GE Lunar Visceral Fat SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2011 · cites it directly1descendant
- K103265Nhanes Whole Body Dxa Reference DatabaseHologic, Inc. · 2011 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935454 | DPX Tissue Quantification Output | Lunar Corp. | 1995 | — |
| −1 | K973459 | Norland Body Composition Option for Norland Dexa Bone Densitometers | Norland Corp. | 1998 | — |
| 0 (this device) | K071570 | GE Lunar Body Composition Software | Ge Medical Systems Lunar | 2007 | — |
| +1 | K113286 | Encore 14 Software Release for the GE Lunar Dxa Bone Densitometers | Ge Medical Systems Lunar | 2012 | — |
| +1 | K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016 | 1 |
| +2 | K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019 | 1 |
| +1 | K103730 | GE Lunar Visceral Fat Software | Ge Medical Systems Ultrasound and Primary Care Dia | 2011 | — |
| +1 | K103265 | Nhanes Whole Body Dxa Reference Database | Hologic, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K973459 | Norland Body Composition Option for Norland Dexa Bone DensitometersSummary page 1…Bone Densitometer, 21 CFR 892.1170, 90-KGI 3. Marketed Device: Body Composition Software Option for Norland DEXA Bone Densitometers K973459 currently in commercial distribution. 4. Device Description: The Body Composition Software Option for GE Lunar DEXA Bone Densitom… | 1998 |
| * | — | GE Lunar Prodigy Total Body Software option Named without a submission number |
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113286 | Encore 14 Software Release for the GE Lunar Dxa Bone Densitometers | 2012 | 5 |
| K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | 2016 | 4 |
| K103730 | GE Lunar Visceral Fat Software | 2011 | 1 |
| K103265 | Nhanes Whole Body Dxa Reference Database | 2011 | 1 |
| K091325 | Ten-Year Fracture Risk Option and Siri Table Option for Norland Dxa Bone Densitometers | 2009 | 0 |
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 12 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K113286 (Ge Medical Systems Lunar, 2012) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K973459.
How does its category compare?
All KGI devicesKGI 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
2026 to Oct 25, outlined.
Median 510(k) review, days · KGI
156in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGI
8in 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 Body Composition Software option (body composition) used on GE Lunar DEXA bone densitometer measures the regional and whole body bone mineral density (BMD), lean and fat tissue mass and calculates derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat…
Read the full statement (210 words)
The GE Lunar Body Composition Software option (body composition) used on GE Lunar DEXA bone densitometer measures the regional and whole body bone mineral density (BMD), lean and fat tissue mass and calculates derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass Index (BMI). The values can be displayed in user-defined statistical formats and trends with color image mapping, and compared to reference populations at the sole discretion of the health care professional.
These body composition values are useful to health care professionals in their management of diseases/conditions where the disease/condition itself, or its treatment, can affect the relative amounts of patient fat and lean tissue. The GE Lunar Body Composition Software option does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases/conditions for which body composition values are useful include chronic renal failure, anorexia nervosa, obesity, AIDS/HIV and cystic fibrosis. DEXA body composition is a useful alternative to hydrostatic weighing and skin fold measurements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071570 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071570: GE Lunar Body Composition Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071570
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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