FDA Radiology AI Devices

SurgiTwin is a radiological image processing system designed to assist clinicians by enhancing or analyzing medical images to support diagnostic and surgical decision-making processes.

The Sonosite LX and Sonosite PX Ultrasound Systems are medical devices that use pulsed Doppler ultrasound technology to create images of the inside of the body. These systems help clinicians visualize and assess various tissues and organs in real time, supporting diagnosis and treatment decisions.

PRAEVAorta®2 by Nurea is an automated software tool designed to assist clinicians by processing radiological images of the aorta. It helps in analyzing medical images to provide more accurate and efficient assessments, supporting diagnosis and treatment planning related to aortic conditions.

Definium Tempo Select is a stationary X-Ray system developed by GE Hualun Medical Systems. It provides high-quality X-Ray images to help clinicians diagnose and assess various medical conditions through radiologic imaging.

CT:VQ by 4DMedical Limited is a medical imaging system that uses computed tomography (CT) technology to help clinicians visualize and assess the lungs and ventilation. It supports diagnosis and treatment planning by providing detailed ventilation imaging and analysis based on CT scans.

VistaSoft 4.0 and VisionX 4.0 are automated software tools designed to assist clinicians by processing radiological images. They help improve image interpretation to support diagnostic decisions in medical imaging.

Rapid DeltaFuse by iSchemaView Inc. is an image processing system designed for radiological applications. It helps clinicians by efficiently processing and analyzing medical images to support diagnostic decisions.

Brainomix 360 Triage Stroke is a software designed to assist clinicians by automatically triaging and notifying them about stroke-related findings in brain imaging studies. This helps speed up diagnosis and ensures prompt patient treatment.

GBrain MRI by Galileo CDS, Inc is an AI-powered software designed to process MRI images automatically, helping radiologists interpret brain scans more efficiently.

PROMO is a mobile X-ray system designed for use in radiology to capture diagnostic images. This device helps clinicians by enabling flexible and convenient imaging at the point of care, potentially integrating AI for image processing or analysis to support clinical decisions.