FDA Radiology AI Devices

Tempus ECG-AF is an AI-powered software that analyzes standard 12-lead ECG recordings from patients aged 65 and older to detect signs indicating an increased risk of atrial fibrillation or atrial flutter within the next 12 months. It assists clinicians by providing risk notifications based on ECG data, improving early identification of patients who may require further diagnostic follow-up.

The V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System by Samsung Medison Co., Ltd. is a general-purpose diagnostic ultrasound system that acquires ultrasound data and displays it in multiple modes including 2D, Doppler, and 3D/4D. It helps healthcare professionals with imaging and fluid flow analysis across many clinical applications such as fetal, cardiac, abdominal, and musculoskeletal imaging. The system includes AI-based features such as NerveTrack for nerve segmentation, enhancing diagnostic capabilities.

SMART Bun-Yo-Matic CT is an AI-based software tool that helps orthopedic healthcare professionals by automatically segmenting foot and ankle bones from CT images, creating 3D anatomical models, measuring structures, and providing surgical planning visualizations. This supports diagnosis and treatment planning, especially for conditions like hallux valgus, through detailed, interactive reports and templates.

Clarius OB AI is an AI-powered software integrated into the Clarius Ultrasound system that assists healthcare professionals in measuring fetal biometric parameters such as head circumference and femur length using ultrasound images. It automates the detection and measurement process, helping clinicians make accurate assessments during obstetric ultrasound examinations.

The SIS System by Surgical Information Sciences, Inc. is an advanced software tool that assists clinicians, including surgeons, neurologists, and radiologists, by providing detailed visualization and 3D models of specific brain structures. It uses machine learning models trained on high-resolution MR images to aid in planning and guiding deep brain stimulation surgeries and other neurological procedures, helping to precisely locate key brain areas and implanted leads for improved surgical outcomes.

The Radiography 7300 C by Philips Medical Systems DMC GmbH is a stationary X-ray imaging system designed to capture high-quality radiographic images. It assists clinicians by providing detailed X-ray images that are essential for diagnosing various medical conditions involving the chest, bones, abdomen, and other body areas.

Relu Creator is a software program used by dental specialists to manage and analyze dental and craniomaxillofacial medical images. It helps with 3D modeling of patient anatomy through image segmentation and registration, supporting preoperative planning and treatment in dental disciplines like orthodontics and implantology. The software enhances and displays images from multiple sources and stores them for easy access, assisting clinicians in planning dental treatments more effectively.

The RS85 Diagnostic Ultrasound System by Samsung Medison is a versatile diagnostic ultrasound device used in a variety of clinical applications such as obstetrics, abdominal, cardiac, musculoskeletal, and peripheral vessel imaging. It provides multiple imaging modes including 2D, Doppler, and 3D/4D imaging and incorporates AI technology for nerve detection and segmentation to aid clinicians in diagnosis and procedures. This system helps healthcare professionals obtain high-quality ultrasound images and quantitative analysis to improve patient care.

The Cardiac CT Function Software Application by Circle Cardiovascular Imaging is a software tool that assists medical professionals in analyzing cardiac function from multi-phase, multi-slice cardiovascular CT angiography images. It uses AI to segment cardiac structures and compute key function metrics such as volume and ejection fraction, helping clinicians evaluate heart function more accurately and efficiently.

Corvair is an AI-powered software that analyzes resting ECG recordings to detect various heart rhythms, morphological abnormalities, and measure ECG intervals. It supports healthcare professionals by providing an initial automated interpretation of ECGs to assist in cardiac diagnosis, enhancing accuracy and efficiency in clinical settings.