# K980125: Reference Population for Norland Apollo X-Ray Bone Densitometer

- Pathway: 510(k) (Traditional)
- Applicant: Norland Corp.
- Decided: May 20, 1998 after 126 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 K931996 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931996: Model Pdexa Bone Densitometer, Norland Corp. (1995) Summary page 1.
- K973104: Norland Model Pdexa Bone Densitometer, Norland Corp. (1998). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K993337: Apollo Multi-Racial Reference Population (2000), 0 descendants of its own

## Indications for use
The bone density estimates from the Apollo™ can be compared to estimates of young normal Caucasian men and women, and as an aid to physicians in diagnosing and managing osteoporosis. The bone density estimates from the Apollo™ can be used as an aid to physicians in determining fracture risk.

Source page: https://510kreport.com/device/K980125
Methodology: https://510kreport.com/methodology