# K161682: GE Lunar DXA Bone Densitometers with enCORE version 17

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Decided: Dec 2, 2016 after 168 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K890121 (1990). 25 ancestors in all.
4 later devices descend from it; 2 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)
- K071570: GE Lunar Body Composition Software, Ge Medical Systems Lunar (2007) Summary page 6.
- K113286: Encore 14 Software Release for the GE Lunar Dxa Bone Densitometers, Ge Medical Systems Lunar (2012) Summary page 6.
- K072664: GE Lunar Femur Strength Software, Ge Medical Systems Ultrasound and Primary Care Dia (2008) Summary page 6.
- K011917: Advanced Hip Assessment Software, Ge Lunar Corp. (2001) Summary page 6.
- K130277: Single Energy (SE) Femur Exams, Hologic, Inc. (2013) Summary page 6.

## Most influential descendants
- K191112: GEHC DXA Bone Densitometers with enCORE version 18 (2019), 2 descendants of its own
- K252718: Lunar Astra (2026), 0 descendants of its own
- K251022: 3D-Shaper (2025), 0 descendants of its own
- K180782: Aria (2018), 0 descendants of its own

## Recalls of this device
- Dec 3, 2019 · Class II · Z-1711-2020: An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

## Indications for use
Optional Atypical Femur Fracture (AFF) software uses Femur images to visualize focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. This software provides measurements of the lateral and medial cortex width and quantifies focal thickening of the lateral cortex along the femoral shaft. The beaking index can be displayed and trended across serial scans. Optional sarcopenia software calculates values based on published definitions and thresholds using measured appendicular lean mass in combination with patient demographics and entered values of muscle strength and physical performance. These values may be useful to health care professionals in their management of sarcopenia.

Source page: https://510kreport.com/device/K161682
Methodology: https://510kreport.com/methodology