# K042480: Infant Whole Body Software Option for QDR Densitometers

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Oct 29, 2004 after 46 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 K973104 (1998). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023398: Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery, Hologic, Inc. (2002) Summary page 1.
- K961787: Body Composition Software Option for QDR X-Ray Bone Densitometers, Hologic, Inc. (1997) Summary page 1.

## Most influential descendants
- K133664: Encore Version 16 Software for GE Lunar Dxa Bone Densitometers (2014), 0 descendants of its own

## Indications for use
The Infant Whole Body software option for QDR X-Ray Bone Densitometers is an optional data acquisition and analysis method that provides estimates of bone mineral content (BMC, in grams), bone mineral density (BMD, in grams/cm 2), and body composition (lean body mass and fat mass of non-osseous tissues) in human infants from birth to one year of age. These data may be used at the discretion of a physician where medically necessary.

Source page: https://510kreport.com/device/K042480
Methodology: https://510kreport.com/methodology