# K103730: GE Lunar Visceral Fat Software

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Ultrasound and Primary Care Dia
- Decided: May 6, 2011 after 136 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 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.

Source page: https://510kreport.com/device/K103730
Methodology: https://510kreport.com/methodology