# K082317: GE Lunar Frax 10-Year Fracture Risk Software Option

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Sep 26, 2008 after 44 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: 2 generations back to K973104 (1998). 3 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983271: Fracture Risk Assessment Option for DPX Series Bone Densitometers, Lunar Corp. (1998) Summary page 1.
- K983028: Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W, Hologic, Inc. (1998) Summary page 1.

## Most influential descendants
- K152299: TBS iNsight (2016), 4 descendants of its own
- K191112: GEHC DXA Bone Densitometers with enCORE version 18 (2019), 2 descendants of its own
- K202514: EchoS Family (2021), 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 FRAX TM 10-Year Fracture Risk software option is an accessory to currently marketed GE Lunar 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. This software option is intended to provide an assessment of 10-year fracture risk. The option provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the patient's age, sex, country, ethnicity, height, weight, femur neck BMD T-score, and the presence or absence of several risk factors and is computed using the FRAXTM Fracture Risk Assessment Tool endorsed by the World Health Organization (WHO). The tool has been validated for men and post-menopausal women between 40 and 90 years old. The output is provided in a separate screen display and report that can be viewed or printed or exported to an optional physician report generator tool. The results can be used by a physician in conjunction with 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/K082317
Methodology: https://510kreport.com/methodology