# K133664: Encore Version 16 Software for GE Lunar Dxa Bone Densitometers

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Ultrasound & Primary Care Diagn
- Decided: May 15, 2014 after 167 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: 4 generations back to K973104 (1998). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001812: Pediatric Reference Data, Lunar Corp. (2000) Summary page 2.
- K042480: Infant Whole Body Software Option for QDR Densitometers, Hologic, Inc. (2004) Summary page 2.
- K972517: Expert-XL Orthopedic Hip Acquisition and Analysis Software, Lunar Corp. (1997) Summary page 2.

## Recalls of this device
- Dec 3, 2019 · Class II · Z-1710-2020: 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
The optional "Complete Pediatric" software option measures bone mineral content (BMC), bone mineral density (BMD) and body composition (lean body mass and fat mass) in patients from birth to 20 years of age. The software provides a comparison of measured variables obtained by dual energy x-ray absorptiometry to a database of reference values for patients 5-19 years of age. These data can be used for comparative purposes at the sole discretion of the physician. The software does not provide a reference population for comparative purposes for patients younger than 5 years of age. Optional Orthopedic software estimates periprosthetic BMD of an orthopedic hip or knee implant (pre- and post-surgery).

Source page: https://510kreport.com/device/K133664
Methodology: https://510kreport.com/methodology