AI-CVD— 510(k) K252029
Substantially EquivalentHeartLung Corporation
FDA 510(k) clearance K252029 for AI-CVD, Substantially Equivalent on 2025-12-19. Applicant: HeartLung Corporation.
Clearance details
- Applicant
- HeartLung Corporation
- Product code
- Code QIH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.