# K974437: Expert-XL Lateral Spine BMD Acquisition and Analysis Software

- Pathway: 510(k) (Traditional)
- Applicant: Lunar Corp.
- Decided: Feb 13, 1998 after 81 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 K945526 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945526: Lunar Expert, Lunar Corp. (1995) Summary page 1.

## Indications for use
The EXPERT-XL Lateral Spine BMD Acquisition and Analysis software is used with the EXPERT-XL bone densitometer system. This software feature estimates bone mineral density (BMD) of the lumbar spine vertebrae in the lateral view. This BMD value can then be compared to a reference population at the sole discretion of the physician.

Source page: https://510kreport.com/device/K974437
Methodology: https://510kreport.com/methodology