K243239
- 510(k) number
- K243239
- Device name
- Lung AI (LAI001)
- Applicant
- Exo, Inc. CA · US
- Product code
- MYN — Analyzer, Medical Image
- Decision date
- 2025-04-24
- Date received
- 2024-10-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243239.pdf
Official FDA record: K243239
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.