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.

Syngo.CT CaScoring by Siemens is an AI-based software that evaluates non-contrasted cardiac CT images to identify and score calcified coronary lesions. It helps clinicians by automatically marking these lesions, assigning them to specific coronary arteries, and calculating clinically relevant scores such as the Agatston score, facilitating better assessment and documentation of coronary artery disease.

FDA #
K201034
Product Code
JAK

Al-Rad Companion (Musculoskeletal) is AI-powered software designed to analyze CT images of the spine. It supports clinicians by automatically segmenting and labeling vertebrae, measuring vertebral heights, and calculating the mean Hounsfield unit values within vertebrae, aiding in musculoskeletal disease evaluation and assessment.

FDA #
K193267
Product Code
JAK

syngo.CT CaScoring is a post-processing software that assists physicians in evaluating and documenting calcified coronary artery lesions using CT scans. It calculates detailed calcium scores for the coronary arteries and generates reports to aid in cardiac risk assessment, helping clinicians detect and quantify coronary artery disease.

FDA #
K192763
Product Code
JAK

AI-Rad Companion (Cardiovascular) is an AI-powered software that analyzes previously acquired CT chest images to segment the heart and aorta, quantify coronary calcium, and measure aortic diameters. It assists clinicians by providing quantitative and qualitative cardiovascular assessments to support diagnosis and evaluation in emergency, specialty, and general practice care.

FDA #
K183268
Product Code
JAK

AI-Rad Companion (Pulmonary) is advanced software designed to analyze CT images of the lungs. It helps clinicians by segmenting lung regions, measuring lung volumes, identifying areas with abnormal tissue density, and detecting lung lesions including solid pulmonary nodules. This enables efficient and precise assessment of lung disease from existing CT scans, supporting better diagnosis and treatment decisions in emergency and specialty care.

FDA #
K183271
Product Code
JAK
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