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.Via RT Image Suite is a software tool designed to help clinicians visualize, manipulate, and contour medical images from various imaging modalities such as CT, MRI, and PET. It supports 3D and 4D image visualization and assists with the segmentation of tumors and organs-at-risk to aid in radiation therapy planning and response assessment. The software incorporates AI techniques, including deep learning-based contouring, to improve the accuracy and efficiency of treatment preparation, thereby enhancing patient care in radiation therapy.

FDA #
K192065
Product Code
MUJ

RayStation is a software system designed to assist radiation therapy staff in planning and analyzing radiation treatments. It uses patient imaging data from CT, PET, and MRI scans to create detailed treatment plans that optimize radiation delivery while protecting healthy tissue. The system includes features like image fusion, contouring, dose computation, and machine learning to optimize and adapt treatment plans efficiently, helping clinicians deliver precise and effective cancer therapy.

FDA #
K190387
Product Code
MUJ
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