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FDA-cleared K242240

CaRi-Plaque

Caristo Diagnostics Ltd.

Authorized purpose: CaRi-Plaque is a web-based post-processing tool for trained operators and healthcare professionals that analyzes previously acquired CCTA DICOM data for coronary plaque characteristics, plaque burden, luminal stenosis, and related vessel measurements.

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2025-02-20