Turn this list into an evaluation

Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.

Prepare with a buyer guide:

Clinical guide links appear when this list contains a current reviewed example. They do not classify or endorse the other entries. All buyer guides · Compare exact records · Documented families

FDA-cleared K223855

FEops HEARTguideTM, FEops HEARTguideTM ALPACA

FEops nv

Authorized purpose: Enable visualization and measurement of heart and vessel structures for preprocedural planning and sizing of structural-heart interventions, including LAAO and TAVI; qualified clinicians use the results with clinical history, symptoms, other evaluations, and professional judgment, and the results do not replace implant-device instructions for final device selection or placement.

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