FDA Radiology AI Devices

DeepContour (V1.0) is a software tool that uses deep learning to automatically segment organs on CT images for radiation therapy planning. It helps trained healthcare professionals by generating and editing organ contours, performing 3D reconstruction, and analyzing anatomical structures. By automating these tasks, it improves workflow efficiency and supports precise radiation treatment planning.

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.

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.

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.

uOmnispace.MR is advanced software developed by Shanghai United Imaging Healthcare Co., Ltd. that helps clinicians view, process, and analyze magnetic resonance (MR) images across various clinical applications such as brain, breast, cardiac, vascular, and neurological imaging. It supports interpretation and evaluation by providing tools for stitching, dynamic studies, spectroscopy, perfusion, vessel analysis, cardiac function analysis, and flow analysis, enabling improved diagnostic workflows and patient care.

VisAble.IO is a software tool that helps physicians plan and evaluate liver ablation treatments by processing CT and MRI images. It assists in identifying treatment targets, planning needle placement virtually, and confirming the treatment area post-procedure to improve procedure accuracy and patient outcomes.

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.

AI-Rad Companion (Pulmonary) by Siemens Healthcare GmbH is software that uses machine learning and deep learning to analyze previously acquired chest CT scans. It helps radiologists and physicians segment lungs and lung lobes, identify and measure solid and sub-solid lung nodules, and track changes over time. This supports clinicians in assessing lung diseases, improving workflow efficiency and diagnostic accuracy.

EdgeFlow UH10 is a handheld ultrasound device designed to noninvasively measure urine volume in the bladder. It uses deep learning AI to detect and outline the bladder in ultrasound images, calculates bladder volume, and displays results on its touchscreen. It supports both B-mode and harmonic imaging, helping healthcare professionals quickly assess bladder volume accurately and efficiently.

The iCAS-LV software from HighRAD Ltd. is an advanced image analysis tool that helps physicians visualize and evaluate liver lesions in CT scans. It uses interactive segmentation, automatic registration, and volume measurement to track lesions' size, shape, and changes over time, supporting clinical decision-making without replacing physician judgment.