K242919
- 510(k) number
- K242919
- Device name
- V5med Lung AI
- Applicant
- V5med, Inc. TW
- Product code
- OEB — Lung Computed Tomography System, Computer-Aided Dete
- Decision date
- 2025-03-27
- Date received
- 2024-09-24
- 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: K242919.pdf
Official FDA record: K242919
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.