# K993337: Apollo Multi-Racial Reference Population

- Pathway: 510(k) (Traditional)
- Applicant: Norland Medical Systems, Inc.
- Decided: May 16, 2000 after 224 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: 2 generations back to K931996 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980125: Reference Population for Norland Apollo X-Ray Bone Densitometer, Norland Corp. (1998) Summary page 1.
- K980569: Fracture Risk Assessment Capability for Norland X-Ray Bone Densitometers, Norland Corp. (1998) Summary page 1.

## Indications for use
The bone density estimates from the Apollo™ bone densitometer can he compared to gender and ethnic matched reference populations as an aid in determining the presence of bone disease other than age-related bone loss. T-Score, % Young Reference, Z-Score, % Age Matched, and long and short term change values are provided. These reference populations include Caucasian, Afro-American, Hispanic, and Asian men and women. The Apollo bone density estimates can be used as an aid to physicians in determining fracture risk.

Source page: https://510kreport.com/device/K993337
Methodology: https://510kreport.com/methodology