# K052581: Lunar Idxa

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Ultrasound and Primary Care Dia
- Decided: Oct 20, 2005 after 30 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: 3 generations back to K890121 (1990). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915535: Forearm Software for Lunar DPX Series Bone Desitom, Lunar (1992) Summary page 1.
- K982267: DPX-RX Bone Densitometer, Lunar Corp. (1998) Summary page 1.
- K983564: Prodigy Total Body Software, Lunar Corp. (1998) Summary page 1.
- K000826: Prodigy Lateral View Software, Lunar Corp. (2000) Summary page 1.
- K001756: Lunar Report Generator II, Lunar Corp. (2000) Summary page 1.
- K001812: Pediatric Reference Data, Lunar Corp. (2000) Summary page 1.
- K011917: Advanced Hip Assessment Software, Ge Lunar Corp. (2001) Summary page 1.
- K023554: Dual-Energy Vertebral Assessment View Software, Ge Lunar Corp. (2002) Summary page 1.

## Most influential descendants
- K252718: Lunar Astra (2026), 0 descendants of its own

## Recalls of this device
- Dec 3, 2019 · Class II · Z-1709-2020: 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 Lunar iDXA Bone Densitometer provides an estimate of bone mineral density and fat and lean tissue mass. The values can then be compared to a reference population at the sole discretion of the physician.

Source page: https://510kreport.com/device/K052581
Methodology: https://510kreport.com/methodology