FDA-cleared K253172

MediAI-OA

Crescom Co., Ltd.

Assist trained professionals in assessing radiographic knee osteoarthritis and its sclerosis, joint-space-narrowing, and osteophyte features on standing fixed-flexion knee...

Modality
X-ray/Radiography
Anatomy
Knee joint
Decision
2026-06-15
FDA-cleared K250914

MediAI-BA

Crescom Co., Ltd.

View and quantify bone age from 2D posteroanterior left-hand radiographs to aid pediatric radiologists assessing patients aged 2-18 years.

Modality
X-ray/Radiography
Anatomy
Left hand and wrist; skeletal maturity/bone age
Decision
2025-12-18