K223811
- 510(k) number
- K223811
- Device name
- Lung-CAD
- Applicant
- Imagen Technologies, Inc. NY · US
- Product code
- MYN — Analyzer, Medical Image
- Decision date
- 2023-09-13
- Date received
- 2022-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K223811.pdf
Official FDA record: K223811
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.