# K103265: Nhanes Whole Body Dxa Reference Database

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Mar 16, 2011 after 132 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K935454 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071570: GE Lunar Body Composition Software, Ge Medical Systems Lunar (2007) Summary page 2.

## Most influential descendants
- K113356: Hologic Visceral Fat Software (2012), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K103265
Methodology: https://510kreport.com/methodology