FDA Radiology AI Devices
Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.
510k6/13/2023
CAC Software by Imbio, Inc. is a machine learning-based post-processing tool that analyzes non-contrast CT images of the chest to assess calcified plaques in the coronary arteries. It quantifies the calcification burden by producing scores and metrics that help clinicians evaluate coronary artery disease risk. The software outputs annotated images and a detailed report, integrating into the standard DICOM workflow to assist physicians without making standalone diagnoses.
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