# K113286: Encore 14 Software Release for the GE Lunar Dxa Bone Densitometers

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Lunar
- Decided: Apr 27, 2012 after 172 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 K935454 (1995). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 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 1.

## 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
- 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

## Indications for use
The GE Lunar enCORE software used on the GE Lunar bone densitometer total body scan estimates the Resting Metabolic Rate (RMR) in the male or female population age 18 and older. The data can be displayed in user-defined statistical formats and trends. The GE Lunar enCORE software used on the GE Lunar bone densitometer total body scan estimates the Relative Skeletal Muscle Index (RSMI) in the male or female population age 18 and older. The data can be displayed in user-defined statistical formats and trends. The Mirrorlmage fuinction in the enCORE software used on the GE Lunar DXA bone densitometers can be used to estimate the total body composition and bone mineral density (BMLD) when regions of the body are outside of the scan window by using scanned data from the corresponding region(s) on the opposite half of the body.

Source page: https://510kreport.com/device/K113286
Methodology: https://510kreport.com/methodology