# K021527: Sectra Osteoporosis Package

- Pathway: 510(k) (Special)
- Applicant: Sectra-Imtec AB
- Decided: Jun 7, 2002 after 28 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 K002500 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002500: X-Posure System Version 2 Rad, Pronosco A/S (2000) Summary page 2.

## Indications for use
The device is intended for use to estimate bone mineral density (“BMD”) in the forearm and to assess increased risk of osteoporotic fracture according to World Health Organization (“WHO”) criteria. The device is indicated specifically for use to: (1) assist the physician in diagnosing subjects who already have been identified to be at risk for suffering from osteoporosis, together with other known risk factors (e.g., prior history of fractures, advanced age, low body weight, lack of physical exercise, lack of exposure to sunlight, insufficient dietary intake of vitamin D and/or calcium, and smoking); and (2) compare the BMD estimate with a reference population comprised of young normals and age-matched normals to compute T-scores and Z-scores, respectively.

Source page: https://510kreport.com/device/K021527
Methodology: https://510kreport.com/methodology