FDA Radiology AI Devices

Hyper Insight - ICH is an AI-powered clinical software tool that analyzes brain CT scans to detect suspected intracranial hemorrhage. It provides timely notifications to medical specialists to prioritize patient care, helping clinicians triage potential emergencies more efficiently. The software serves as a supplementary notification aid rather than a definitive diagnostic tool, enhancing workflow efficiency and supporting faster treatment decisions.

VEA Align and spineEOS are cloud-based medical imaging software products by EOS imaging designed to assist healthcare professionals. VEA Align helps assess spinal and lower limb alignment using 2D X-rays with AI-generated anatomical landmarks for precise angle and length measurements. spineEOS facilitates preoperative planning for spine surgeries with access to 3D spine datasets and clinical measurements, enabling tailored surgical strategies. Both tools support clinicians by improving diagnostic accuracy and surgical planning through advanced image analysis and AI.

The O-arm O2 Imaging System by Medtronic Navigation, Inc is a mobile X-ray device designed to provide detailed 2D and 3D imaging of patients' bony anatomy and metallic objects, mainly used during image-guided surgeries. It includes advanced software features such as metal artifact reduction and dose reduction using machine learning, helping clinicians obtain clearer images with lower radiation exposure for improved surgical navigation and patient safety.

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.

Medihub Prostate is a semi-automatic image processing software designed for analyzing prostate MR images. It uses AI to outline the prostate region semi-automatically and supports radiologists and urologists in reviewing MR data. The software requires user editing and confirmation, enhancing the accuracy of prostate volume measurements and analysis, aiding clinical decision-making without replacing the expert's judgment.

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.

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.

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 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.