# K071570: GE Lunar Body Composition Software

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Lunar
- Decided: Jun 27, 2007 after 19 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: 2 generations back to K935454 (1995). 2 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973459: Norland Body Composition Option for Norland Dexa Bone Densitometers, Norland Corp. (1998) Summary page 1.
- (no number) GE Lunar Prodigy Total Body Software option: named in the summary without a submission number

## Most influential descendants
- K113286: Encore 14 Software Release for the GE Lunar Dxa Bone Densitometers (2012), 5 descendants of its own
- K161682: GE Lunar DXA Bone Densitometers with enCORE version 17 (2016), 4 descendants of its own
- K191112: GEHC DXA Bone Densitometers with enCORE version 18 (2019), 2 descendants of its own
- K103730: GE Lunar Visceral Fat Software (2011), 1 descendant of its own
- K103265: Nhanes Whole Body Dxa Reference Database (2011), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K071570
Methodology: https://510kreport.com/methodology