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FDA-cleared K243859

PRAEVAorta®2

Nurea

Authorized purpose: PRAEVAorta 2 assists clinical specialists, physicians, and other licensed practitioners with automatic vascular segmentation and maximum-diameter measurement on adult CT images; results require clinical assessment and physician validation when obtained by a non-physician.

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2025-08-29