# K983269: Fracture Risk Assessment Option for Expert-XL Bone Densitometer

- Pathway: 510(k) (Traditional)
- Applicant: Lunar Corp.
- Decided: Nov 18, 1998 after 62 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Norland-Cameron Model 178 Bone Mineral Analyzer: named in the summary without a submission number

## Indications for use
The Fracture Risk option is used with the LUNAR EXPERT-XL bone densitometer system. This option provides an assessment of relative fracture risk based on the patient’s T-score value using the categories of fracture risk defined by the World Health Organization (WHO). Physician and patient information is provided to indicate that although bone density is the single most important factor in the assessment of fracture risk and the diagnosis of osteoporosis, the physician should also consider other factors.

Source page: https://510kreport.com/device/K983269
Methodology: https://510kreport.com/methodology