# K023554: Dual-Energy Vertebral Assessment View Software

- Pathway: 510(k) (Traditional)
- Applicant: Ge Lunar Corp.
- Decided: Dec 20, 2002 after 58 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 K950611 (1995). 3 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000826: Prodigy Lateral View Software, Lunar Corp. (2000)
- K950611: Expert Morphomerty Softward, Lunar Corp. (1995) Summary page 1.
- K992775: Option for the QDR Bone Densitometer, Models QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W, Hologic, Inc. (1999) Summary page 1.

## Most influential descendants
- K103475: Spineanalyer Model Sapoc (2011), 2 descendants of its own
- K052581: Lunar Idxa (2005), 1 descendant of its own
- K252718: Lunar Astra (2026), 0 descendants of its own
- K171435: VirtuOst Vertebral Fracture Assessment (2018), 0 descendants of its own
- K120288: Orthocad Software Option (2012), 0 descendants of its own

## Indications for use
Dual-energy Vertebral Assessment View Software is used with the Prodigy bone densitometer. This software provides an x-ray image of the spine for qualitative visual assessment in order to identify vertebral deformations and estimate vertebral heights (morphometry). The use of the Prodigy Bone Densitometer is restricted to prescription use only. The operator’s manual for the Prodigy 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/K023554
Methodology: https://510kreport.com/methodology