# K941127: QCT-Bone Mineral Analysis Software

- Pathway: 510(k) (Traditional)
- Applicant: Image Analysis, Inc.
- Decided: May 11, 1995 after 428 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K031991: Dxaview Spine and Hip, Model QCT-3D Plus (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K941127
Methodology: https://510kreport.com/methodology