K253172
- 510(k) number
- K253172
- Device name
- MediAI-OA
- Applicant
- Crescom Co., Ltd. KR
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-06-15
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253172.pdf
Official FDA record: K253172
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.