# K091325: Ten-Year Fracture Risk Option and Siri Table Option for Norland Dxa Bone Densitometers

- Pathway: 510(k) (Traditional)
- Applicant: Cooper Surgical
- Decided: Jun 29, 2009 after 55 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: 3 generations back to K935454 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080711: 1.10-Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometer, Model QDR Option, Hologic, Inc. (2008) Summary page 1.
- K071570: GE Lunar Body Composition Software, Ge Medical Systems Lunar (2007) Summary page 1.

## Indications for use
Ten-Year Fracture Risk Option The Ten-Year Fracture Risk Option for the Norland DXA Bone Densitometeters uses the femoral neck T-Score, along with certain clinical risk factors, to estimate the patient's ten-year risk of a hip fracture and/or a major osteoporodic fracture, based on the FRAX algorithm developed by the World Health Organization (WHO). This information is useful to health care professional as they manage diseases or conditions relating to bone health. This option does not diagnose disease or recommend treatment. SIRI Table Option The SIRI Table Option for the Norland DXA Bone Densitometers uses the SIRI UWE % Fat value, and plots it on the industry standard body fat charts. The chart used depends on the patient's gender and age, and it indicates whether the patient is Underfat, Healthy, Overfat, or Obese. These charts are the result of work done by the National Institute of Health (National Heart, Lung, and Blood Institute), who assigned underfat to obese classifications to the BMI value; and by Tanita Corporation, who related BMI to % body fat based on DXA bone densitometry. This option also calculates the patient's Body Mass Index (BMI) based solely on the height and weight data inputted by the operator, as a convenience. This information is useful to health care professional as they manage diseases or conditions relating to or affected by the patient's relative amount of fat tissue. This option does not diagnose disease or recommend treatment.

Source page: https://510kreport.com/device/K091325
Methodology: https://510kreport.com/methodology