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.

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.

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.

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.

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.

The VIVIX-S 1751S is a digital flat panel X-ray detector designed for general-purpose diagnostic radiographic procedures. It replaces traditional film/screen X-ray systems by capturing and converting X-ray photons into digital images. This helps clinicians obtain high-quality digital X-ray images quickly and efficiently for better diagnosis.

EchoGo Amyloidosis (1.0) is an automated AI decision support system that analyzes 2D echocardiograms (specifically apical four chamber view) to screen for cardiac amyloidosis in adults over 65 years with heart failure. It helps clinicians by classifying patients as suggestive or not suggestive of cardiac amyloidosis, enabling referral for confirmatory testing. The AI was trained on large datasets and validated clinically to ensure accuracy and safety.

Fetal EchoScan is an AI-powered software tool that assists physicians in analyzing fetal heart ultrasound videos during the second trimester. It helps identify suspicious anatomical findings that may indicate fetal congenital heart defects, enhancing diagnostic accuracy and aiding clinical decision-making without replacing standard care.