FDA-cleared K223855
FEops HEARTguideTM, FEops HEARTguideTM ALPACA
FEops nv
Enable visualization and measurement of heart and vessel structures for preprocedural planning and sizing of structural-heart interventions, including LAAO and TAVI; qualified...
- Modality
- CT/CTA
- Anatomy
- Heart and cardiovascular vessels, including the left atrium, left atrial appendage, aortic root/ascending aorta, and left ventricle
- Decision
- 2023-06-06