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.

MIM – Symphony HDR Fusion is an advanced medical imaging software designed to assist trained clinicians with processing and analyzing multiple imaging modalities such as CT, MRI, PET, and ultrasound. It supports fusion and registration of images, contouring of tumors and tissues, and planning for high dose rate brachytherapy treatments. By integrating image visualization, catheter digitization, and dose planning, it helps clinicians optimize radiation therapy for cancer patients safely and effectively.

FDA #
K243012
Product Code

Contour ProtégéAI by MIM Software Inc. is an AI-powered software tool that helps trained medical professionals automatically create contours of anatomical structures on CT and MRI scans. The software uses machine-learning algorithms to segment normal organs and tissues, aiding in quantitative analysis and radiation therapy planning. It is intended to improve workflow efficiency and treatment accuracy by automating tedious contouring tasks.

FDA #
K213976
Product Code
QKB
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