FDA Radiology AI Devices

The ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems by Siemens are advanced diagnostic ultrasound devices that provide detailed imaging and signal data inside the body for clinical diagnosis. They are intended for a wide range of clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and pediatric imaging. These systems integrate AI-powered tools such as AI Abdomen for semi-automated view classification and measurement in abdominal ultrasound, and Trace AI for semi-automated measurements of anatomical structures in cardiac imaging, improving efficiency and accuracy for clinicians.

The Natus BrainWatch System is a portable EEG monitoring device that records and visually presents EEG signals to assist trained medical personnel in neurological diagnosis for patients aged 2 years and older. It features a disposable headband with integrated electrodes, wireless connectivity, and cloud storage, enabling rapid and convenient EEG monitoring in healthcare settings.

The Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) is a medical imaging device used in clinical settings to non-invasively measure the stiffness and attenuation properties of liver tissue using ultrasound shear wave elastography. It aids clinicians in the diagnosis and monitoring of liver diseases by providing quantitative elastography metrics in a portable and easy-to-use system.

CT Collaboration Live is a software application integrated into Philips CT systems that enables real-time remote communication for consultation, training, and support via chat, audio/video calls, screen sharing, and remote control. It facilitates collaboration between CT system operators and remote clinical users but is not intended for remote diagnostic image review.

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.

1CMR Pro is a medical software tool that helps clinicians view and analyze cardiovascular MRI images. It automates analysis of heart structure, function, and blood flow, improving the accuracy and precision of cardiac assessments. This supports better diagnosis and monitoring of heart diseases.

CORIOGRAPH Pre-Op Planning and Modeling Services is a software tool used for preoperative planning of orthopedic surgeries such as unicondylar knee replacement, total knee arthroplasty, and primary total hip arthroplasty. It generates patient-specific bone models and surgical plans based on medical imaging scans, helping surgeons plan and optimize implant placement before surgery.

Koios DS is an artificial intelligence software tool that helps trained physicians analyze ultrasound images of breast lesions and thyroid nodules. It processes user-selected regions within the images to provide AI-derived risk assessments for cancer, and generates descriptors following established medical lexicons to improve diagnostic accuracy and reduce variability among physicians. The software also functions as an image viewer and supports image annotation and reporting, helping clinicians make more informed decisions in managing patients with suspicious lesions.

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is an AI-based software tool that analyzes adult chest X-rays to detect critical conditions such as pleural effusion and pneumothorax. It prioritizes cases in the clinical workflow by providing passive notifications in the radiologist's PACS or workstation, helping healthcare professionals manage urgent cases efficiently. The software supports DICOM and common image formats and is intended to assist rather than replace clinical decision-making.