# K980289: Fracture Risk Assessment for the Norland Sxa 3000 Bone Densitometer

- Pathway: 510(k) (Traditional)
- Applicant: Norland Corp.
- Decided: Jun 12, 1998 after 137 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 K973104 (1998). 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)
- K973104: Norland Model Pdexa Bone Densitometer, Norland Corp. (1998). Cleared while this submission was under review Summary page 1.

## Indications for use
The bone density estimates from the SXA 3000™ can be used as an aid to physicians in determining fracture risk, based on their comparison to estimates for people without bone related disease, who have the same gender and ethnic background as the patient.

Source page: https://510kreport.com/device/K980289
Methodology: https://510kreport.com/methodology