# K061561: Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone Densitometers

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Jul 28, 2006 after 53 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 K890121 (1990). 16 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 30 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 3.
- K011917: Advanced Hip Assessment Software, Ge Lunar Corp. (2001) Summary page 3.

## Most influential descendants
- K072664: GE Lunar Femur Strength Software (2008), 7 descendants of its own
- K082402: Osdx Hip BMD System (2008), 6 descendants of its own
- K121716: TBS Insight (2012), 5 descendants of its own
- K161682: GE Lunar DXA Bone Densitometers with enCORE version 17 (2016), 4 descendants of its own
- K152299: TBS iNsight (2016), 4 descendants of its own

## Indications for use
The Hip Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio.

Source page: https://510kreport.com/device/K061561
Methodology: https://510kreport.com/methodology