# K980569: Fracture Risk Assessment Capability for Norland X-Ray Bone Densitometers

- Pathway: 510(k) (Traditional)
- Applicant: Norland Corp.
- Decided: Jun 12, 1998 after 119 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.
4 later devices descend from it; 4 cite it directly.
0 of 6 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) Summary page 1.
- (no number) Fracture Risk Assessment for the Norland-Cameron Model 178 Bone Mineral Analyzer: named in the summary without a submission number

## Most influential descendants
- K993176: Multi-Racial Reference Population for Pdexa and Discovery (2000), 0 descendants of its own
- K993337: Apollo Multi-Racial Reference Population (2000), 0 descendants of its own
- K992125: XR 46 Dxa (Central) Bone Densitometer, Model XR 46 (1999), 0 descendants of its own
- K983273: XCT 2000 L PQCT Bone Densitometer (1998), 0 descendants of its own

## Indications for use
The bone density estimates from Norland X-Ray Bone Densitometers can be used as an aid to the physician in determining risk of fracture.

Source page: https://510kreport.com/device/K980569
Methodology: https://510kreport.com/methodology