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FDA-cleared K231683

inHEART Models

inHEART, SAS

Authorized purpose: Create, review, analyze, annotate, export, and use 3D cardiac models to support reading, reporting, and therapeutic-intervention planning.

Modality
CT/CTA; MRI
Anatomy
Cardiac structures, including the aorta, atria, ventricles, pulmonary artery trunk, and right atrium/inferior vena cava structures described in the FDA performance table
Decision
2024-02-29