FDA Radiology AI Devices

SIGNA MAGNUS is a high-performance, head-only 3.0T magnetic resonance imaging (MRI) system designed to capture detailed images of the head, neck, TMJ, and limited cervical spine. It supports various imaging planes and advanced diffusion techniques to produce high-resolution images that assist physicians in diagnosis, helping improve patient care through better imaging quality and shorter scan times.

Sonic DL is a software feature by GE Healthcare that uses deep learning to reconstruct cardiac MR images much faster by processing under-sampled data. It allows highly accelerated imaging with preserved image quality, enabling faster and more efficient MRI scans for cardiac assessment in patients of all ages.

Critical Care Suite with Pneumothorax Detection AI Algorithm by GE Medical Systems is an AI-based software tool that analyzes frontal chest X-rays to detect pneumothorax. It highlights areas of concern and provides a confidence score, helping radiologists and licensed healthcare professionals prioritize cases and accurately diagnose pneumothoraces more efficiently. The software can be integrated with existing PACS and X-ray imaging systems to streamline workflow.

Auto Segmentation by GE Medical Systems is an AI software tool that automatically generates organ-at-risk contours from CT scans to help radiation oncologists, medical physicists, and dosimetrists speed up radiation therapy planning. It produces initial segmentation contours that users can review and adjust, improving workflow efficiency and precision in radiation treatment.

Spectral Bone Marrow is an automated deep learning-based software designed for spectral CT images of the body and extremities. It segments bone regions and creates enhanced, color-coded images to help radiologists better visualize bone marrow. This assists in diagnosing traumatic and non-traumatic bone conditions more efficiently by providing improved image visualization and an automated clinical workflow.

Venue Fit is a compact, portable diagnostic ultrasound system designed for use by trained healthcare professionals. It provides high-quality ultrasound imaging and fluid flow analysis across multiple clinical applications. The system supports standard ultrasound modes and includes AI-assisted features such as nerve tracking to help clinicians during procedures. Venue Fit enhances imaging capabilities and workflow efficiency in hospital and clinical settings.

Venue by GE Medical Systems is a general-purpose diagnostic ultrasound system designed for use by trained healthcare professionals. It offers ultrasound imaging, measurement, and analysis of the human body and fluids in a variety of clinical settings including hospitals and clinics. The device supports multiple clinical applications across different body regions and features automated tools to improve clinical workflow. Venue also includes AI-powered tools such as cNerve which assists in nerve detection and tracking during nerve block procedures, enhancing precision and patient safety.

AIR Recon DL is a deep learning-based software feature for GE Healthcare MRI systems that improves image quality by reducing noise and ringing artifacts in MRI images. It helps clinicians by enabling shorter scan times without losing image clarity, thus improving patient comfort and diagnostic accuracy across multiple anatomies and MR field strengths.

Deep Learning Image Reconstruction (DLIR) by GE Medical Systems is an AI-powered CT image reconstruction method that uses a deep neural network to produce high-quality cross-sectional images of the head and whole body. It supports multiple CT acquisition types and enhances image quality by reducing noise and artifacts, helping clinicians get clearer and more accurate imaging results.

Critical Care Suite with Endotracheal Tube Positioning AI Algorithm is a software tool that uses AI to automatically analyze frontal chest X-rays. It detects and localizes the position of an endotracheal tube and calculates the distance between the tube tip and the carina, providing clinicians with important information on tube placement to improve patient care.