FDA Radiology AI Devices

Saige-Dx by DeepHealth, Inc is an AI-powered software that assists radiologists by automatically analyzing DBT mammograms and associated 2D images to detect potential soft tissue lesions and calcifications that might indicate breast cancer. It provides suspicion levels for findings and the entire case to support physicians during screening mammogram interpretation, improving diagnostic accuracy and efficiency.

The ACUSON Redwood Diagnostic Ultrasound System is a multi-purpose ultrasound device designed for a wide range of clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and more. It uses advanced ultrasonic pulsed Doppler and various imaging modes to help healthcare professionals visualize internal body structures and measure anatomical features, assisting in clinical diagnosis and patient management, such as assessing liver fat content. It supports both 2D and advanced combined imaging modes and integrates specialized features like Ultrasound-Derived Fat Fraction (UDFF) for aiding in hepatic steatosis evaluation.

The 5000 Compact Series Ultrasound Systems by Philips Ultrasound LLC is a diagnostic ultrasound imaging system equipped with an AI-powered Auto Measure feature. It provides semi-automated, editable 2D and Doppler measurements primarily for adult echocardiography, helping clinicians obtain accurate cardiac measures efficiently. The system supports a wide range of clinical applications including cardiac, abdominal, vascular, obstetric, and musculoskeletal imaging, and is used in various clinical settings such as hospitals and clinics.

ProFound Detection V4.0 is an AI-powered software designed to assist radiologists by detecting suspicious soft tissue densities and calcifications in 3D digital breast tomosynthesis (DBT) images. It helps identify potential malignant lesions by marking findings and providing confidence scores, thus supporting earlier and more accurate breast cancer detection during image interpretation.

icobrain aria is a software tool that helps radiologists detect and assess amyloid-related abnormalities in brain MRI scans of Alzheimer's disease patients undergoing antibody treatment. It uses AI to highlight and measure edema and microhemorrhages, aiding in clinical decisions and monitoring disease progression safely and effectively.

NeuroICH is a software tool designed to analyze non-contrast CT scans of the head using artificial intelligence to detect signs of intracranial hemorrhage. It provides notifications to specialist clinicians via a mobile app, helping to prioritize patient care without replacing standard diagnostic procedures.

The Symbia Pro.specta VA30A Family by Siemens is a hybrid SPECT/CT imaging system designed for healthcare professionals to help detect, localize, diagnose, and monitor various diseases including cardiovascular, neurological disorders, and cancer. It combines physiological imaging from SPECT with anatomical imaging from CT, enabling accurate assessment and radiotherapy planning. The device also supports low dose lung cancer screening and advanced image analysis software to assess and quantify pathologies.

The Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) by Telefield Medical Imaging is a portable, software-controlled ultrasound system designed for real-time visualization of anatomical structures and blood flow using B-mode, color Doppler, and pulsed wave imaging. It aids healthcare professionals by providing detailed imaging and fluid flow analysis across multiple body regions such as abdominal, musculoskeletal, and vascular areas, facilitating diagnosis at the point of care.

EchoMeasure by iCardio.ai is an AI-powered software that analyzes previously acquired cardiac ultrasound images to automatically measure key cardiac anatomical parameters. It assists cardiologists and healthcare professionals by providing accurate measurements for clinical decision-making, enhancing efficiency and supporting diagnostic review.

The EPIQ Series Diagnostic Ultrasound System by Philips is an advanced ultrasound imaging device that uses AI-powered software to aid clinicians in semi-automated quantification of heart valve function, specifically assessing the tricuspid valve and mitral valve regurgitation. This helps improve accuracy and efficiency in diagnosing cardiac conditions by providing detailed measurements and flow analysis from 3D ultrasound images.