# K983262: Fracture Risk Assessment Option for Pixi Bone Densitometers

- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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

## Most influential descendants
- K033550: DXL Calscan (2004), 0 descendants of its own

## Indications for use
The Fracture Risk option is used with the LUNAR PIXI 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. The use of the Fracture Risk option for PIXI is restricted to prescription use only. The operator’s manual for the PIXI 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.” The Fracture Risk option for PIXI poses no new safety or efficacy concerns.

Source page: https://510kreport.com/device/K983262
Methodology: https://510kreport.com/methodology