K240554
- 510(k) number
- K240554
- Device name
- InferRead Lung CT.AI
- Applicant
- Infervision Medical Technology Co., Ltd. CN
- Product code
- OEB — Lung Computed Tomography System, Computer-Aided Dete
- Decision date
- 2025-05-16
- Date received
- 2024-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240554.pdf
Official FDA record: K240554
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.