FDA Radiology AI Devices

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.

The BeneVision Central Monitoring System is a networked patient monitoring solution designed for use in professional healthcare settings. It enables clinicians to remotely view, store, and manage physiological data and alarms from various compatible monitors and anesthesia devices, including ECG and cardiac data. This system improves patient care by providing real-time and historical patient data access and supports alarm notifications to caregivers, enhancing clinical decision-making and patient safety.

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.

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.

The EnSite™ X EP System is a computerized diagnostic tool that helps visualize and map the electrical activity of the heart during electrophysiological procedures. It displays the 3D position of catheters inside the heart and creates detailed maps of cardiac chambers to aid clinicians in diagnosing and treating heart rhythm disorders.