FDA Radiology AI Devices

Navigo Workstation 2.3 is a medical image processing system designed for radiology. It helps clinicians analyze radiological images by providing advanced image processing tools to assist in diagnosis and medical decision-making.

RiasDR is a software product designed to acquire and process digital radiographic images, helping clinicians by efficiently managing and enhancing X-ray images for diagnosis and treatment planning.

The InVision™ 3T Recharge Operating Suite is a system designed for magnetic resonance imaging (MRI). It helps clinicians by providing high-quality images of the body’s internal structures, aiding in diagnosis and treatment planning. This advanced MRI system supports detailed and clear imaging, improving patient care in radiology.

iPETcertum (v1.0) by Claritas HealthTech Pte Ltd is a radiological image processing system designed to assist clinicians by analyzing medical images to support patient diagnosis and management.

The uMR Jupiter is an MRI system developed by Shanghai United Imaging Healthcare Co., Ltd. It produces detailed images of the body's internal structures using nuclear magnetic resonance, aiding clinicians in diagnosis and treatment planning.

The INNOVISION-DXII is a stationary X-Ray system used in radiology to capture high-quality X-ray images. It helps clinicians by providing reliable imaging for diagnosing various conditions, facilitating accurate patient assessment and treatment planning.

The Deepsight NeedleVue LC1 Ultrasound System is an imaging device that uses pulsed echo ultrasound technology. It helps clinicians visualize internal anatomy in real-time to guide procedures such as needle placements more accurately and safely.

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.

The Biograph Trinion is a combined PET/CT imaging system designed to provide high-resolution fusion of metabolic and anatomical information. It assists healthcare professionals in detecting, diagnosing, staging, and managing diseases such as cancer, cardiovascular disorders, and neurological conditions. The system also supports radiotherapy planning and interventional procedures, enhancing diagnostic accuracy and patient care.

Genius AI Detection 2.0 is a software tool that uses artificial intelligence and deep learning to help radiologists detect and evaluate potential breast abnormalities in 3D mammography (digital breast tomosynthesis) images. It marks suspicious soft tissue densities and calcifications, provides confidence scores, and supports radiologists in their interpretation during the exam reading, enhancing breast cancer screening accuracy and efficiency.