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.

YSIO X.pree is a digital stationary X-ray system designed to create X-ray images of various body parts including the skull, chest, abdomen, and extremities. It helps medical professionals visualize anatomical structures to support diagnosis and treatment. The system features updated software, new wireless detectors, and AI-based functions like auto-cropping and automatic collimation to improve image quality and ease of use.

uOmnispace.CT is a comprehensive medical image management and processing software mainly for CT images, developed by Shanghai United Imaging Healthcare. It provides various AI-driven analysis tools including lung nodule detection, brain perfusion analysis, cardiovascular and liver evaluations, and more. This software supports clinical interpretation, visualization, and quantitative assessment, helping clinicians diagnose and plan treatments more efficiently across multiple organ systems.

Heuron ICH is an artificial intelligence software that assists medical specialists by analyzing non-contrast head CT images to identify suspected cases of intracranial hemorrhage. It provides notifications and compressed preview images to help prioritize patient care and streamline workflow, without modifying the original images or serving as a diagnostic device.

BriefCase-Quantification is an AI-powered software that analyzes CT scans of the abdominal aorta to measure its maximum diameter. It helps trained medical specialists by providing preliminary diameter measurements to assist with evaluating normal and aneurysmal abdominal aortas, improving the efficiency of radiological assessments. The software is cloud-based, processes images from DICOM format, and integrates output with PACS for clinician review.

SmartChest is an AI software that analyzes frontal chest X-rays to detect suspected pleural effusion and pneumothorax. It helps radiologists by prioritizing cases with critical findings in their worklists, improving workflow efficiency. The software passively notifies the radiologist without replacing clinical decision-making.

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.

The CT 5300 by Philips Healthcare is an advanced computed tomography system designed to produce detailed cross-sectional images of the head, body, cardiac and vascular structures. It supports various CT applications including diagnostic and low-dose lung cancer screening. The system uses AI-enhanced image reconstruction to provide high quality images at reduced radiation dose, helping clinicians detect and analyze anatomical features and abnormalities.

The ECHELON Synergy V10.0 MRI system by Fujifilm Healthcare Americas Corporation is an advanced magnetic resonance imaging device that produces detailed cross-sectional images of the body using non-ionizing magnetic fields. It helps physicians diagnose various conditions by providing high-quality images reflecting tissue properties such as proton density and relaxation times. This system includes updated software features with AI-powered image processing to improve image quality and workflow efficiency, benefiting both clinicians and patients.

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.