FDA Radiology AI Devices

Syngo Carbon Enterprise Access (VA40A) is a software-only medical device developed by Siemens Healthcare GmbH for use in healthcare institutions. It provides an enterprise-wide web application to display and render DICOM and non-DICOM medical data, supporting image and result distribution for diagnostic use by trained medical professionals. The software facilitates standardized data access without controlling image acquisition and enhances clinical workflows with a user-friendly interface. It does not include automated diagnostic functions but supports quality display and management of medical images and documents.

RAYDENT SW is software that helps dental professionals plan treatments and design orthodontic and prosthetic devices by using 3D imaging data and simulations. It assists in creating treatment plans and designing devices such as clear aligners, crowns, veneers, and bridges, improving precision and efficiency in dental care.

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.

The AEYE-DS device helps healthcare providers automatically detect more than mild diabetic retinopathy in adults with diabetes by analyzing retinal images taken by specific fundus cameras. It uses AI technology to analyze the images and provides diagnostic screening results, improving early detection and management of diabetic eye disease.

Rapid by iSchemaView Inc. is a medical image processing software designed to help clinicians analyze CT and MRI images, including functional and dynamic datasets like CT Perfusion and diffusion-weighted MRI. It facilitates quick visualization, quantification, and interpretation of brain tissue changes often seen in acute stroke, helping physicians select patients for endovascular thrombectomy and assess cerebral hemodynamics. The software supports both standard and C-arm CT images and assists in managing complex imaging data efficiently, enhancing clinical workflow and patient care in neurological emergencies.

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.

The SKOUT system is a computer-aided detection software designed to assist gastroenterologists during colonoscopy by identifying potential colorectal polyps in real time. It highlights suspected polyps on endoscopic video to aid in colorectal cancer screening or surveillance, supporting clinicians in making more accurate evaluations.

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.

The CorVista System with PH Add-On is a non-invasive AI-based medical device that analyzes sensor-acquired cardiac electrical and hemodynamic signals to indicate the likelihood of elevated pulmonary arterial pressure, aiding clinicians in diagnosing pulmonary hypertension. It provides results through a user-friendly digital interface and supports healthcare providers by combining the AI output with clinical judgment.

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.