FDA Radiology AI Devices

The Aplio i900, i800, and i700 Software V9.0 are diagnostic ultrasound systems used for medical imaging. These systems help clinicians visualize internal body structures in real-time using pulsed Doppler ultrasound technology, aiding in diagnosis and treatment planning.

AiORTA - Plan is an AI-powered software that processes radiological images automatically, assisting clinicians by enhancing image analysis workflows in radiology. It helps improve accuracy and efficiency in interpreting medical images.

The LOGIQ E10 is an advanced ultrasound imaging system developed by GE Medical Systems. It uses pulsed Doppler ultrasonic technology to produce detailed real-time images, helping clinicians accurately assess and diagnose patients through non-invasive ultrasound scans.

LOGIQ E10s is an advanced ultrasound imaging system by GE Medical Systems that uses pulsed Doppler technology to produce detailed medical images. It helps clinicians in diagnosing and monitoring patients by providing real-time visualization of internal body structures and blood flow.

The Visions® PV .014P RX and .018 Digital IVUS Catheters are ultrasound devices used inside blood vessels to generate detailed images of the vessel walls. These imaging tools help clinicians diagnose and treat cardiovascular diseases by providing real-time internal views, improving decision-making and patient care.

TheraSphere 360™ Y-90 Management Platform is a radiological image processing system designed to assist clinicians in managing Yttrium-90 therapy treatments. It aids in visualizing and planning therapy using processed medical images, helping clinicians optimize patient outcomes.

The Azurion R3.1 by Philips Medical Systems B.V. is an interventional fluoroscopic X-ray system designed for use in radiology. It aids clinicians by providing real-time X-ray imaging to guide minimally invasive procedures, enhancing the accuracy and safety of interventions.

The Cocoon Solo (DX-7020s) is a digital extraoral X-ray system used in radiology to capture high-quality images, assisting clinicians in dental and maxillofacial diagnosis and treatment planning.

The Mobile X-ray unit (!M1) is a portable X-ray system designed to capture radiographic images outside of traditional imaging suites, providing flexibility for bedside or remote patient imaging. It assists clinicians by enabling quick and accessible diagnostic imaging, potentially integrating with AI tools for enhanced image analysis and diagnosis.

Syngo Carbon Clinicals (VA41) is an automated software solution by Siemens Healthineers designed to assist radiologists by processing radiological images, improving workflow and aiding in diagnostic efficiency.