# K250914: MediAI-BA

- Pathway: 510(k) (Traditional)
- Applicant: Crescom Co., Ltd.
- Decided: Dec 18, 2025 after 266 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
The MediAI-BA 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 18 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. Limitations: – This software is not intended for use in patients with growth disorders caused by congenital anomalies (e.g., Down syndrome, Noonan syndrome, congenital adrenal hyperplasia, methylmalonic acidemia, skeletal dysplasia, chronic renal disease, or prior long-term steroid exposure), as these conditions may cause complex skeletal changes beyond bone maturation. – Images showing anatomical variations or notable abnormalities (e.g., bone tumors, sequelae of fractures, or congenital deformities) in the region required for interpretation are excluded from the intended use.

Source page: https://510kreport.com/device/K250914
Methodology: https://510kreport.com/methodology