# K262390: BoneXpert

- Pathway: 510(k) (Traditional)
- Applicant: Visiana
- Decided: Sep 22, 2026 after 71 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K935595 (1995). 89 ancestors in all.
No later device cites it as a predicate yet.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K234042: EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100), Ever Fortune.Ai, Co., Ltd. (2024) Summary page 5.

## Indications for use
BoneXpert is designed to view and quantify bone age from 20 Posterior Anterior (PA) hand radiographs using machine learning techniques to aid in the analysis of bone age assessment of patients between 2-21 years old for pediatric radiologists. The results should not be relied upon alone to make diagnostic decisions. The images shall be without any major bone deformity and without excessive image postprocessing (edge enhancement).

Source page: https://510kreport.com/device/K262390
Methodology: https://510kreport.com/methodology