FDA-cleared K232613
CT Cardiomegaly
Innolitics, LLC
Authorized purpose: Automatically calculate linear and area-based cardiothoracic ratio from a CT study containing the heart to support clinician assessment of possible cardiomegaly; not for standalone clinical decision-making or diagnosis.
- Modality
- CT/CTA
- Anatomy
- Heart and thoracic cavity (cardiothoracic ratio)
- Decision
- 2024-02-28