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.

MapRT is a software system used by radiotherapy professionals during the CT simulation and treatment planning stages to model 3D patient and equipment geometry. It helps to avoid collisions between the treatment machine, patient, and accessories, and facilitates dose optimization by providing a clearance map for various gantry and couch angles. This improves treatment safety and planning efficiency.

FDA #
K243301
Product Code
IYE

Mobius3D (4.1) is a software tool designed for radiation therapy clinics to perform quality assurance, treatment plan verification, and patient alignment analysis. It calculates three-dimensional radiation dose distributions based on treatment plans and imaging data, helping clinicians verify and ensure accurate radiation therapy without directly interacting with the delivery system or patients.

FDA #
K250099
Product Code
IYE

Ethos Treatment Management 3.0 and Ethos Treatment Planning 2.0 from Varian Medical Systems are software applications designed to assist clinicians in managing, generating, and modifying radiation therapy treatment plans. They incorporate AI-based segmentation algorithms to aid in contouring anatomical structures to improve and streamline radiation therapy planning and monitoring. These tools help improve accuracy and efficiency in radiation treatment for cancer and other diseases requiring radiation therapy.

FDA #
K232923
Product Code
IYE
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