# K983564: Prodigy Total Body Software

- Pathway: 510(k) (Traditional)
- Applicant: Lunar Corp.
- Decided: Dec 8, 1998 after 56 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: 1 generation back to K884625 (1989). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884625: DPX Bone Densitometer for Total Body Bone Density, Lunar (1989) Summary page 1.
- K935454: DPX Tissue Quantification Output, Lunar Corp. (1995) Summary page 1.

## Most influential descendants
- K052581: Lunar Idxa (2005), 1 descendant of its own
- K252718: Lunar Astra (2026), 0 descendants of its own
- K072439: GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile Kit (2007), 0 descendants of its own

## Indications for use
The Total Body Software is used with the Prodigy bone densitometer system. This software provides an estimate of BMD, fat and lean tissue mass. The BMD value can then be compared to a reference population at the sole discretion of the physician. The Total Body Software requires a 5-minute exposure, with a total effective dose of 0.13 mrem. This software is substantially equivalent to the DPX Total Body software and poses no new safety or efficacy concerns. The use of the Prodigy Bone Densitometer is restricted to prescription use only. The operator’s manual for the Prodigy system contains the following statement: “United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician.”

Source page: https://510kreport.com/device/K983564
Methodology: https://510kreport.com/methodology