K251769
- 510(k) number
- K251769
- Device name
- RevealAI-Lung
- Applicant
- Precision Medical Ventures, Inc. Dba Revealdx WA · US
- Product code
- POK — Computer-Assisted Diagnostic Software For Lesions Su
- Decision date
- 2026-01-30
- Date received
- 2025-06-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K251769.pdf
Official FDA record: K251769
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.