K252029
- 510(k) number
- K252029
- Device name
- AI-CVD
- Applicant
- HeartLung Corporation TX · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-12-19
- Date received
- 2025-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252029.pdf
Official FDA record: K252029
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.