# K072664: GE Lunar Femur Strength Software

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Ultrasound and Primary Care Dia
- Decided: Nov 21, 2008 after 428 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 K890121 (1990). 17 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061561: Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone Densitometers, Hologic, Inc. (2006) Summary page 1.
- K011917: Advanced Hip Assessment Software, Ge Lunar Corp. (2001). Our reading of the summary gave K001917, FDA’s number for Parodi Catheter for Angiography (Parca) (Arteria Medical Science, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GE Lunar Prodigy Advanced hip assessment Software option”.

## Most influential descendants
- K161682: GE Lunar DXA Bone Densitometers with enCORE version 17 (2016), 4 descendants of its own
- K191112: GEHC DXA Bone Densitometers with enCORE version 18 (2019), 2 descendants of its own
- K113725: Virtuost (2012), 1 descendant of its own
- K252718: Lunar Astra (2026), 0 descendants of its own
- K251022: 3D-Shaper (2025), 0 descendants of its own

## Indications for use
The GE Lunar Femur Strength analysis software option is an accessory to currently marketed GE Lunar DEXA bone densitometer devices, which are intended to estimate the bone mineral density and body composition (lean and fat tissue mass) of patients when medically indicated by their physicians. The Femur Strength software is intended to measure the hip axis length (HAL) and provides female adult Caucasian and Asian mean reference values of HAL from previously acquired GE Lunar femur scans. The software calculates hip geometry values used to evaluate the structural properties of the hip, such as sub-region lengths, angles, ratios, buckling ratio, section modulus (Z), cortical thickness, cross-sectional area (CSA) and cross-sectional moment of inertia (CSMI). The software calculates a Femur Strength Index (FSI), a strength/stress ratio incorporating geometric properties of the hip such as CSMI, CSA, bone mineral density (BMD), patient age, height and weight. A ScanCheck feature is included to provide online messages to assist the operator or physician in checking that the scan was correctly taken. Color mapping of the variable density of bone images is also provided. The values measured or computed provide additional information about the structure of the hip. They should be used in conjunction with the BMD T-score and other clinical risk factors as an aid in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the assessment of fracture risk.

Source page: https://510kreport.com/device/K072664
Methodology: https://510kreport.com/methodology