FDA Radiology AI Devices

Salix Coronary Plaque (V1.0.0) is an AI-powered software designed to automatically process and analyze radiological images, specifically helping clinicians assess coronary artery plaques to improve cardiac care.

Methinks CTA Stroke is an AI software tool designed to assist clinicians by automatically analyzing CT angiography images of the brain to detect signs of stroke. It helps prioritize urgent cases by providing triage and notification, enabling faster diagnosis and treatment for patients.

The Revolution Vibe is a computed tomography (CT) imaging system developed by GE Medical Systems. It captures detailed cross-sectional X-ray images of the body, aiding clinicians in diagnosing and monitoring various conditions with high clarity and speed.

NextAR Spine is an augmented reality surgical navigation platform designed to help surgeons precisely locate anatomical structures during spine surgery. It uses CT imaging and intraoperative scans to guide the placement of screws and other instruments in the thoracic and lumbosacral spine, improving surgical accuracy and patient outcomes.

Marie is a computed tomography (CT) X-Ray system designed to capture detailed cross-sectional images of the body, aiding clinicians in diagnosing and monitoring various medical conditions through advanced imaging techniques.

HeartFlow Analysis is a software tool that uses advanced imaging and computational models to simulate coronary vascular physiology. It helps clinicians assess blood flow in the coronary arteries non-invasively, aiding in diagnosis and treatment planning for cardiac patients.

Rapid CTA 360 by iSchemaView is an AI software designed to assist radiologists by automatically triaging and notifying critical findings on CT angiography scans. This helps clinicians quickly identify urgent conditions and prioritize patient care effectively.

The SOMATOM go series by Siemens Medical Solutions USA, Inc., comprises advanced CT scanner systems used in radiology to produce detailed cross-sectional images of the body. These devices assist clinicians by providing high-quality computed tomography images that support diagnosis and treatment planning for various medical conditions.

The Philips iCT CT System is a computed tomography scanner designed for diagnostic imaging of the head, body, cardiac, and vascular regions. It produces detailed cross-sectional images by reconstructing X-ray data taken from multiple angles, aiding clinicians in diagnosing a range of conditions. The system offers updated hardware and software improvements for enhanced image quality, cybersecurity, and usability without altering its core imaging capabilities.

The Dental CBCT X-ray System by Yian Medical Technology is a dental imaging device that produces 2D panoramic, cephalometric images, and 3D cone-beam CT images of the dental, oral, and maxillofacial region. It aids healthcare professionals in diagnosing adult and pediatric patients, providing detailed digital X-ray images for dental and oral care.