K252029

Substantially Equivalent

AI-CVD

Applicant: HeartLung Corporation
Product code: QIH
Advisory panel: Radiology
Date received: 2025-06-30
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.