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 assist clinicians in viewing, manipulating, and contouring 3D and 4D medical images from various modalities such as CT, PET, MRI, and CBCT. It helps prepare radiation therapy treatment plans by enabling visualization, semi-automatic and automatic contouring of tumors and organs, image registration, and image fusion. The software improves workflow efficiency and treatment accuracy in radiation oncology.

FDA #
K232799
Product Code
MUJ

ART-Plan (v.2.2.0) is a medical software platform designed to help clinicians involved in radiotherapy for cancer patients. It allows users to contour regions of interest on 3D images, perform image registration and fusion from multiple imaging modalities (CT, MRI, CBCT), generate synthetic CT images using deep learning, and support decision-making for treatment replanning. This assists medical professionals in precisely targeting radiation therapy and adapting treatment based on daily patient imaging data, improving safety and treatment efficacy for cancer patients aged 18 and above.

FDA #
K234068
Product Code
MUJ

ART-Plan is a radiotherapy treatment planning software that assists clinicians by visualizing and fusing multimodal medical images, automatically segmenting organs and lymph nodes using AI, generating synthetic CT images from MR and CBCT scans, computing dose distributions for radiation therapy, and aiding in treatment adaptation decisions. It enhances workflow efficiency and accuracy for trained professionals managing radiotherapy for cancer patients.

FDA #
K232479
Product Code
MUJ

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 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

Oncospace is a software tool that assists radiation oncologists and medical dosimetrists in planning radiotherapy treatments for patients with cancer in the prostate, head, and neck regions. It uses locked machine learning algorithms to predict achievable dose objectives for organs at risk based on the patient's anatomy and automates aspects of treatment plan optimization. This helps clinicians customize treatment protocols, optimize radiation dose delivery while sparing healthy tissue, and review treatment plans efficiently, ultimately supporting better patient care in radiation oncology.

FDA #
K222803
Product Code
MUJ

The syngo.via RT Image Suite by Siemens is advanced software that helps clinicians visualize and manipulate 3D and 4D medical images from multiple modalities like CT, MRI, PET, and CBCT. It supports contouring tumors and organs at risk, image registration, and creating simple treatment plans, aiding radiation therapy preparation. The software includes AI-based deep learning for lung lobe segmentation to calculate lung ventilation, improving the accuracy and efficiency of radiation therapy planning.

FDA #
K220783
Product Code
MUJ

MRI Planner is a software tool for radiation oncologists and medical physicists that uses MRI images to help plan radiotherapy treatments. It generates synthetic CT images and automatically outlines certain healthy anatomical structures to assist in treatment planning, particularly for cancers in the brain, head-neck, and pelvic regions. This helps improve the accuracy and efficiency of radiotherapy planning without manually contouring from scratch.

FDA #
K211841
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
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