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.

Contour ProtégéAI+ is a medical imaging software accessory that leverages machine-learning algorithms to automatically create contours of anatomical structures on CT and MR images. It supports clinicians by automating and assisting in image segmentation, which is critical for adaptive therapy, radiation treatment planning, and patient follow-up. The software provides significant time savings and improves contouring consistency, while allowing clinicians to review and edit results as needed.

FDA #
K250035
Product Code
QKB

Contour+ (MVision AI Segmentation) is a software tool that uses machine learning algorithms to automatically create contour outlines of anatomical regions on CT and MRI scans. It assists clinicians in radiation therapy planning by providing initial segmentations of organs and tissues, which professionals can review and modify before treatment planning. This speeds up the workflow and improves efficiency in radiation treatment preparation.

FDA #
K241490
Product Code
QKB

Limbus Contour is a software tool designed to help medical professionals automatically create accurate contours of healthy anatomical structures from CT and MRI images. These contours are used to plan and evaluate radiation treatment for cancer patients, improving efficiency and consistency in treatment preparation.

FDA #
K241837
Product Code
QKB

AI-Rad Companion Organs RT is an AI-powered medical imaging software designed to automatically segment organs from CT and MR scans to assist radiation therapy treatment planning. It uses deep learning algorithms to produce contours of organs-at-risk, which clinicians can review and edit before using them in treatment planning systems. This software saves time and improves the accuracy of radiation therapy preparation by providing automated organ delineation, intended for use by trained medical professionals.

FDA #
K232899
Product Code
QKB

ART-Plan is a medical imaging software that helps clinicians visualize, contour, and process 3D multi-modal images like CT, MR, and PET-CT for cancer patients undergoing radiotherapy. The software uses AI to automatically delineate organs at risk and lymph nodes to assist in treatment planning, saving time and improving precision. It also supports image registration and generation of synthetic CT images from MRI.

FDA #
K230023
Product Code
QKB

ART-Plan is an advanced software tool designed to assist medical professionals in cancer radiotherapy planning. It supports visualization and manipulation of 3D multi-modal medical images (CT, MR, PET-CT, CBCT, 4D-CT) and includes AI-driven automatic and semi-automatic segmentation of organs at risk and lymph nodes. It also allows image registration and generation of synthetic CT images from MRI, facilitating precise and efficient radiation treatment planning.

FDA #
K220813
Product Code
QKB

Contour ProtégéAI by MIM Software Inc. is an AI-powered software tool that helps trained medical professionals automatically create contours of anatomical structures on CT and MRI scans. The software uses machine-learning algorithms to segment normal organs and tissues, aiding in quantitative analysis and radiation therapy planning. It is intended to improve workflow efficiency and treatment accuracy by automating tedious contouring tasks.

FDA #
K213976
Product Code
QKB
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