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.

MOZI TPS is a radiation therapy planning software that helps clinicians design and optimize treatment plans for patients with malignant or benign diseases. It uses medical images to assist in contouring anatomical structures automatically with deep learning, performs image registration, and calculates radiation dose distribution using Monte Carlo algorithms. This aids clinicians in accurately planning external beam irradiation with photon beams, improving treatment effectiveness and patient safety.

FDA #
K223724
Product Code
MUJ

The Radiation Planning Assistant (RPA) is a web-based software tool designed to automate and assist in planning radiation therapy for cancers of the head and neck, cervix, breast, and brain metastases. It uses CT images to create contours and treatment plans with photon beam irradiation, improving efficiency and precision in radiotherapy treatment planning. The system generates outlines of organs and tumors and proposes radiation dose plans, which clinicians then review and adjust in their own treatment planning systems before use.

FDA #
K222728
Product Code
MUJ

RayStation 11B is a radiation therapy treatment planning software that helps clinicians create, analyze, and manage radiation treatment plans for cancer patients. The software integrates imaging data, including CT and CBCT, to compute radiation doses accurately and supports the administration of treatments, improving clinical workflow and patient care.

FDA #
K220141
Product Code
MUJ

INTContour is a software tool that uses machine learning to automatically identify and outline organs and treatment targets on medical images to aid radiation therapy planning. This helps clinicians by providing initial segmentations that can be reviewed and edited, saving time and improving efficiency in treatment preparation for cancer patients.

FDA #
K212274
Product Code
MUJ

AI Segmentation is a cloud-based software product that uses artificial intelligence to automatically segment anatomical structures from CT images. It is designed to assist medical professionals in radiation therapy treatment planning by providing automated contours of organs in regions such as the head and neck, thorax, pelvis, and abdomen. The segmented structures can be reviewed, edited, and approved by qualified treatment planners and physicians to streamline planning and improve accuracy.

FDA #
K211881
Product Code
MUJ

AI Segmentation by Varian Medical Systems is a cloud-based AI software tool that segments patient anatomical structures from CT scans to assist radiation therapy treatment planning. It automatically delineates organs at risk in regions such as head and neck, thorax, pelvis, and abdomen, helping radiation therapy professionals by streamlining contouring tasks and integrating with treatment planning systems, though clinicians review and approve the results.

FDA #
K203469
Product Code
MUJ
Page 1 of 16 results
1

Ready to Sharpen Your Edge?

Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.