510(k) · Cleared
ClearedGE Lunar Visceral Fat Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Ultrasound and Primary Care Dia · KGI Densitometer, Bone
Cleared on May 6, 2011 as substantially equivalent to K071570 (Ge Medical Systems Lunar, 2007) after a 136-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- May 6, 2011
- Review
- 136 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935454 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK935454 DPX Tissue Quantification OutputLunar Corp. · 1995
- 2 generations backK973459 Norland Body Composition Option for Norland Dexa Bone DensitometersNorland Corp. · 1998
- 1 generation backK071570 GE Lunar Body Composition SoftwareGe Medical Systems Lunar · 2007
- This deviceK103730 GE Lunar Visceral Fat SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2011
- Descendant · cites it directly · 0 of its ownK113356 Hologic Visceral Fat SoftwareHologic, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K113356Hologic Visceral Fat SoftwareHologic, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935454 | DPX Tissue Quantification Output | Lunar Corp. | 1995 | — |
| −2 | K973459 | Norland Body Composition Option for Norland Dexa Bone Densitometers | Norland Corp. | 1998 | — |
| −1 | K071570 | GE Lunar Body Composition Software | Ge Medical Systems Lunar | 2007 | — |
| 0 (this device) | K103730 | GE Lunar Visceral Fat Software | Ge Medical Systems Ultrasound and Primary Care Dia | 2011 | — |
| +1 | K113356 | Hologic Visceral Fat Software | Hologic, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (1)
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 |
|---|---|---|---|
| * | K071570 | GE Lunar Body Composition SoftwareSummary page 2…ar Visceral Fat Software option for GE Lunar DEXA Bone Densitometers is of comparable type and substantially equivalent to the GE Lunar Body Composition Software option (K071570). It has the same technological characteristics, is comparable in key safety and effectiveness features, it utilizes similar desi… | 2007 |
| † | K963345 | Advantage Windows Tissue Volume Option | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113356 | Hologic Visceral Fat Software | 2012 | 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 16 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K113356 (Hologic, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K071570.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Visceral Fat Software option used on GE Lunar DEXA bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in a male or female population between the age of 18 and 90 with a BMI between 18.5 and 40, excluding pregnant women. The content that is estimated is the Visceral Fat Mass and Visceral Fat Volume. The values can be displayed in user defined statistical formats and…
Read the full statement (169 words)
The GE Lunar Visceral Fat Software option used on GE Lunar DEXA bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in a male or female population between the age of 18 and 90 with a BMI between 18.5 and 40, excluding pregnant women. The content that is estimated is the Visceral Fat Mass and Visceral Fat Volume. The values can be displayed in user defined statistical formats and trends.
The estimated visceral fat content is 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 visceral fat content in the android region. The GE Lunar Visceral Fat 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 visceral fat estimation is useful include hypertension, impaired fasting glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia, and metabolic syndrome.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K103730 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103730: GE Lunar Visceral Fat Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103730
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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