# K031991: Dxaview Spine and Hip, Model QCT-3D Plus

- Pathway: 510(k) (Special)
- Applicant: Image Analysis, Inc.
- Decided: Jul 30, 2003 after 33 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 K883280 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992246: QCT Bone Mineral Analysis Software, Image Analysis, Inc. (1999) Summary page 1.
- K941127: QCT-Bone Mineral Analysis Software, Image Analysis, Inc. (1995) Summary page 1.
- K943505: Hologic QDR-3000 X-Ray Bone Densitometer, Hologic, Inc. (1995) Summary page 1.
- K002113: Ctxa Hip; Ctxa; QCT Pro Ctxa Hip, Mindways Software, Inc. (2001) Summary page 1.

## Indications for use
The DXAVIEW™ Hip and Spine bone densitometry Options are intended to provide estimates of bone mineral density (BMD) and bone mineral content (BMC) in the proximal femur and spine. Young normal reference data taken from caucasian populations can be used to calculate T-Scores. Age matched normal reference data are used to calculate Z-Scores. The BMD results, along with the T- and Z-Scores, can be used by physicians in their determination of fracture risk and therapy effectiveness.

Source page: https://510kreport.com/device/K031991
Methodology: https://510kreport.com/methodology