K250914
- 510(k) number
- K250914
- Device name
- MediAI-BA
- Applicant
- Crescom Co., Ltd. KR
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-12-18
- Date received
- 2025-03-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K250914.pdf
Official FDA record: K250914
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.