FDA Radiology AI Devices

syngo.CT Extended Functionality is a software package that provides advanced visualization and measurement tools for medical images acquired from CT and potentially other modalities like MRI. It helps technicians and physicians perform qualitative and quantitative analysis of clinical imaging data to assist in diagnosis by creating detailed images and measurements using various specialized extensions.

ProstatID is an AI software tool designed to assist radiologists by analyzing prostate MRI scans to identify and assess suspicious lesions that may indicate prostate cancer. It processes MRI images and provides detection overlays, lesion likelihood scores, 3D renderings, and a summary report to support diagnostic decisions for high-risk screening or diagnostic imaging.

The V8 and V7 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound imaging systems designed for a wide range of clinical applications including obstetrics, abdominal, cardiac, musculoskeletal and more. They produce ultrasound images and enable fluid analysis, incorporating features like Doppler imaging and AI-supported nerve detection to help clinicians make accurate diagnoses in real-time.

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.

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.

The MAGNETOM Free.Max and MAGNETOM Free.Star are advanced magnetic resonance imaging (MRI) systems designed by Siemens. These devices produce detailed cross-sectional images of the body to help clinicians visualize internal structures and diagnose various conditions. Featuring new software and hardware enhancements, they provide improved imaging workflows, patient comfort with different bore sizes, and automated shoulder examination support, aiding physicians in accurate diagnosis and patient management.

CoLumbo is a medical imaging AI software tool designed to assist radiologists and spine surgeons by automatically segmenting and measuring lumbar spine features from MRI images. It highlights out-of-range measurements and generates reports for review and approval by clinicians, improving the efficiency and consistency of lumbar spine evaluation, but does not provide diagnosis.

Venue Go is a portable, general-purpose diagnostic ultrasound system designed for use by trained healthcare professionals to image and analyze the human body and fluid flow. It supports a wide range of clinical applications including abdominal, cardiac, vascular, musculoskeletal, and more. It offers advanced imaging modes and AI-enhanced tools such as cNerve for nerve tracking, aiding clinicians during procedures like nerve blocks. This device helps clinicians obtain high-quality ultrasound images and analyze them efficiently to improve patient care.

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.

ElucidVivo A.3 is a medical image analysis software that processes and visualizes CT angiographic images to help physicians assess arterial vessels and stratify patients with atherosclerosis. It offers tools for measurement and visualization of vessel structure and plaque characteristics, supporting clinical decision-making without providing direct diagnosis.