FDA-cleared K231683
inHEART Models
inHEART, SAS
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