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.

RayStation 12A by RaySearch Laboratories is a comprehensive radiation therapy treatment planning system that allows users to import patient images, define treatment targets, optimize and evaluate radiation treatment plans, and administer them. It supports multiple imaging modalities including CT, PET, and MR, enhancing precision in oncologic care by helping clinicians design effective and tailored radiation treatments while ensuring safety and accuracy.

FDA #
K222312
Product Code
MUJ

RayStation 11.0 is a software system used in radiation therapy and medical oncology for planning, analyzing, and administering treatment plans. It helps clinicians design and optimize radiation treatments accurately based on the patient's medical imaging data, enhancing treatment effectiveness and safety.

FDA #
K211867
Product Code
MUJ

RayStation 10.1 is a software platform used to plan, analyze, and administer radiation therapy treatment and medical oncology. It helps clinicians generate and review treatment plans based on imaging data and user input, including advanced features like brachytherapy and ocular proton treatment planning. This system supports improved treatment accuracy and workflow efficiency for radiation oncology professionals.

FDA #
K210645
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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