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.

RayCare (2024A SP1) is a software system designed to support cancer treatment by assisting clinicians with treatment planning, management, scheduling, and follow-up for radiation therapy and oncology care. It includes an image viewer for reviewing and annotating images related to patient positioning during treatment, aiding clinicians in delivering precise radiotherapy treatment.

FDA #
K242992
Product Code
MUJ

Vitesse (5.0) is a treatment planning software designed for medical professionals to assist in planning, guiding, optimizing, and documenting high-dose-rate brachytherapy procedures. It supports real-time ultrasound guidance, image import and export via DICOM standards, and visualization of complex imaging data including PET and MR scans. This software helps clinicians create and manage radiation treatment plans accurately and efficiently, improving patient care in radiation therapy.

FDA #
K241876
Product Code
MUJ
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