# K080711: 1.10-Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometer, Model QDR Option

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Sep 2, 2008 after 173 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K973104 (1998). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963363: Hologic QDR Series X-Ray Boe Densitometers, Hologic, Inc. (1996) Summary page 2.
- K983028: Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W, Hologic, Inc. (1998) Summary page 2.

## Most influential descendants
- K091325: Ten-Year Fracture Risk Option and Siri Table Option for Norland Dxa Bone Densitometers (2009), 0 descendants of its own

## Recalls of this device
- Sep 24, 2008 · Not classified · Z-0449-2009: Software error may lead to a high estimate of major fracture probability.

## Indications for use
Femoral neck BMD and clinical risk factors are used to estimate 10-year risk of hip fracture and 10-year risk of major osteoporotic fracture using the World Health Organization (WHO) algorithm (FRAXTM) in adults. The physician may use the 10-year fracture risk, along with the physician's knowledge of patient history, and apply medical expertise and best practice clinical judgment to determine if therapeutic intervention is indicated.

Source page: https://510kreport.com/device/K080711
Methodology: https://510kreport.com/methodology