# K961787: Body Composition Software Option for QDR X-Ray Bone Densitometers

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Jun 13, 1997 after 400 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DPX Tissue Quantitation Output; Lunar Corporation: named in the summary without a submission number
- (no number) CT 9800; General Electric Corporation: named in the summary without a submission number

## Most influential descendants
- K042480: Infant Whole Body Software Option for QDR Densitometers (2004), 1 descendant of its own
- K133664: Encore Version 16 Software for GE Lunar Dxa Bone Densitometers (2014), 0 descendants of its own

## Indications for use
The intended use of the Hologic® Body Composition Software for QDR® X-Ray Bone Densitometers is to estimate the lean body mass and fat mass of non-osseous tissues in situations where medically necessary.

Source page: https://510kreport.com/device/K961787
Methodology: https://510kreport.com/methodology