# K992246: QCT Bone Mineral Analysis Software

- Pathway: 510(k) (Traditional)
- Applicant: Image Analysis, Inc.
- Decided: Sep 3, 1999 after 59 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K113725: Virtuost (2012), 1 descendant of its own
- K220402: VirtuOst (2023), 0 descendants of its own
- K031991: Dxaview Spine and Hip, Model QCT-3D Plus (2003), 0 descendants of its own

## Indications for use
QCT bone densitometry is indicated for patients with suspected loss of bone to identify and/or confirm osteoporosis. QCT of the highly responsive spinal trabecular bone is indicated for early detection of bone loss. QCT is useful for measuring bone loss or gain with time for monitoring osteoporsis therapies. Reduced bone loss by QCT can be related to increased fracture risk by WHO criteria.

Source page: https://510kreport.com/device/K992246
Methodology: https://510kreport.com/methodology