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.

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.

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 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 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 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 REMEX Xcam6 is a portable, handheld mobile X-ray system designed for hospital or clinic use to capture diagnostic X-ray images of patient extremities. It can be used with a flat panel detector to acquire, display, and manipulate images. It enables clinicians to obtain high-quality radiographic images conveniently and safely, aiding the diagnosis of various conditions affecting extremities.

YSIO X.pree is a modular digital X-ray system designed to visualize anatomical structures across the whole body, including the skull, chest, abdomen, and extremities. It helps clinicians by producing high-quality X-ray images that support diagnosis and therapy decisions. The system features updated hardware and software, including a new wireless detector and AI-based auto-cropping and collimation capabilities, enhancing workflow efficiency and image quality.