# K254072: BoneVue

- Pathway: 510(k) (Traditional)
- Applicant: Curvebeam AI / Curvebeam, LLC
- Decided: Sep 11, 2026 after 267 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002113: Ctxa Hip; Ctxa; QCT Pro Ctxa Hip, Mindways Software, Inc. (2001) Summary page 6.

## Indications for use
The BoneVue is intended to measure bone mineral density (BMD) in the proximal femur. It is a post-processing software tool for assessing a patient’s proximal femur BMD from existing CT scans. The BoneVue is not intended to replace DXA or any other tests dedicated to BMD measurement. It is designed for measuring BMD in existing CT scans or CT scans ordered for reasons other than BMD measurement.

Source page: https://510kreport.com/device/K254072
Methodology: https://510kreport.com/methodology