FDA Radiology AI Devices

OsteoSight™ Hip (v1) is a radiology software designed to opportunistically evaluate low bone mineral density from medical images, helping clinicians identify patients at risk for osteoporosis and related fractures.

VELMENI for DENTISTS (V4D) is an AI-powered medical image analyzer designed to assist dental professionals by analyzing medical images. It helps clinicians by providing insights and analysis to improve diagnostic accuracy in dental care.

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.

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.

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.

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.

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.

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.

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.

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.