# K113356: Hologic Visceral Fat Software

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Mar 6, 2012 after 113 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: 4 generations back to K935454 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103730: GE Lunar Visceral Fat Software, Ge Medical Systems Ultrasound and Primary Care Dia (2011) Summary page 3.
- K103265: Nhanes Whole Body Dxa Reference Database, Hologic, Inc. (2011) Summary page 2.

## Indications for use
The Hologic Visceral Fat Software used on Hologic Discovery bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in an adult male or female population, excluding pregnant women. The content that is estimated is the Visceral Fat Area, Visceral Fat Mass, and Visceral Fat Volume. These 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 Hologic Visceral Fat software 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/K113356
Methodology: https://510kreport.com/methodology