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FDA-cleared K221463

ElucidVivo A.3

Elucid Bioimaging Inc.

Authorized purpose: ElucidVivo A.3 postprocesses contrast multidetector CT to visualize arterial vessels and provide semi-automatic lumen boundaries, stenosis and lumen measurements, vessel length, and related values to assist trained physicians in atherosclerosis stratification; measurements complement standard care and are not diagnoses or recommendations.

Modality
CT/CTA
Anatomy
Arterial vessels and atherosclerotic disease
Decision
2022-06-17
FDA-cleared K183012

vascuCAP

Elucid Bioimaging Inc.

Authorized purpose: vascuCAP analyzes contrast multidetector CT of arterial vessels to support atherosclerosis stratification with color maps, three-dimensional views, multiplanar reformats, and measurements for physician review.

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2018-12-21