510(k) · Cleared
ClearedNhanes Whole Body Dxa Reference Database
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · KGI Densitometer, Bone
Cleared on Mar 16, 2011 as substantially equivalent to K071570 (Ge Medical Systems Lunar, 2007) after a 132-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Mar 16, 2011
- Review
- 132 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 deviceK103265 Nhanes Whole Body Dxa Reference DatabaseHologic, Inc. · 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) | K103265 | Nhanes Whole Body Dxa Reference Database | Hologic, Inc. | 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…Densitometer: 21 CER 892.1170 F.3.3 Classification Panel Radiology F.3.4 Product Code 90 KGI F.3.5 Predicate Devices 510(k) No.: K071570 Trade Name: Body Composition Software Option for GE Lunar DEXA Bone Densitometers SE Dat… | 2007 |
| † | K072847 | Apex 2.0 Software for QDR X-Ray Bone Densitometers | 2008 |
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 3.7 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 Hologic Whole Body DXA Reference Database software used on Hologic QDR bone densitometers measures the regional and whole body bone mineral density, lean and fat tissue mass and calculates derivative values of bone mineral content, area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional and total soft tissue mass ratios, % fat, regional % fat, total body %fat, android %fat, gynoid % fat, android/gynoid…
Read the full statement (208 words)
The Hologic Whole Body DXA Reference Database software used on Hologic QDR bone densitometers measures the regional and whole body bone mineral density, lean and fat tissue mass and calculates derivative values of bone mineral content, area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional and total soft tissue mass ratios, % fat, regional % fat, total body %fat, android %fat, gynoid % fat, android/gynoid ratio, and body mass index. 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 and conditions where the disease or conditions itself, or its treatment, can affect the relative amounts of fat and lean tissue. The Hologic Whole Body DXA Reference Database software does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases and conditions for which body composition values are useful include chronic renal failure, anorexia nervosa, obesity, AIDS/Hly, and cystic fibrosis. DXA body composition is a useful alternative to hydrostatic weighting and skin fold measurements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103265: Nhanes Whole Body Dxa Reference Database.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103265
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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