K251203
- 510(k) number
- K251203
- Device name
- AVIEW Lung Nodule CAD
- Applicant
- Coreline Soft Co., Ltd. KR
- Product code
- OEB — Lung Computed Tomography System, Computer-Aided Dete
- Decision date
- 2025-12-03
- Date received
- 2025-04-18
- 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: K251203.pdf
Official FDA record: K251203
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.