FDA Radiology AI Devices

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.

The EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is software that uses deep learning to analyze left-hand X-ray images in pediatric patients aged 2 to 16 years. It estimates bone age to assist pediatric radiologists in clinical decision-making. The system integrates with existing PACS workflows, providing bone age assessments to support but not replace radiologist interpretation.

CINA-VCF is an AI-powered software device designed to analyze chest and abdominal CT scans in patients aged 50 and above to identify suspected vertebral compression fractures. It operates alongside standard imaging workflows to prioritize and notify clinicians of potentially positive cases, helping improve triage speed and efficiency without altering original images or serving as a diagnostic tool itself.

The uPMR 790 by Shanghai United Imaging Healthcare Co., Ltd. is a combined PET and MRI system that simultaneously captures high-resolution metabolic and anatomical images of the body to assist clinicians in diagnosis. It includes advanced AI-based image reconstruction and processing techniques, like DeepRecon for denoising and ACS for accelerated image reconstruction, improving image quality and scan efficiency without radiation exposure from MRI. This helps healthcare providers better assess physiological and anatomical conditions in patients.

LVivo IQS is an AI-powered platform designed to analyze ultrasound images of the heart, specifically providing real-time quality scoring of right ventricle images from the 4-chamber apical view. This software helps clinicians by automatically detecting, measuring, and calculating important cardiac parameters and providing feedback on image quality, enhancing the reliability and interpretability of ultrasound examinations.