# K234042: EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)

- Pathway: 510(k) (Traditional)
- Applicant: Ever Fortune.Ai, Co., Ltd.
- Decided: Jun 7, 2024 after 169 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: 18 generations back to K935595 (1995). 88 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200356: Medo Aria, Medo.Ai (2020) Summary page 4.

## Most influential descendants
- K262390: BoneXpert (2026), 0 descendants of its own
- K250914: MediAI-BA (2025), 0 descendants of its own

## Indications for use
EFAI BONESUITE XR BONE AGE PRO ASSESSMENT SYSTEM (EFAI BAPXR) is designed to view and quantify bone age from 2D Posterior Anterior (PA) view of left-hand radiographs using deep learning techniques to aid in the analysis of bone age assessment of patients between 2 to 16 years old for pediatric radiologists. The results should not be relied upon alone by pediatric radiologists to make diagnostic decisions. The images shall be with left hand and wrist fully visible within the field of view, and shall be without any major bone destruction, deformity, fracture, excessive motion, or other major artifacts.

Source page: https://510kreport.com/device/K234042
Methodology: https://510kreport.com/methodology