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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