FDA Radiology AI Devices

3D-SHAPER is a medical device that analyzes imaging data to measure bone density in three dimensions. It helps clinicians assess bone health more accurately, which is important for diagnosing conditions like osteoporosis and planning treatments.

The ViewMate™ Multi Ultrasound System is an ultrasound imaging device that helps clinicians by providing high-quality pulsed Doppler ultrasonic images. It supports the diagnosis and assessment of various medical conditions by visualizing blood flow and tissue structures in real time.

Rapid Obstructive Hydrocephalus, or Rapid OH, is a computer-assisted software designed to analyze medical images of the brain to quickly identify cases of obstructive hydrocephalus, a condition involving fluid buildup in the brain. This software helps clinicians by providing rapid triage and notification, potentially improving patient outcomes by speeding up diagnosis and treatment.

Careverse CoronaryDoc is an automated software designed for processing radiological images, helping clinicians analyze coronary images more efficiently and accurately.

The device is a dental X-ray system designed to capture extraoral images of patients' teeth and jaws. It assists clinicians in diagnosing dental conditions by providing clear X-ray images, potentially enhanced or interpreted with AI technologies to improve diagnostic accuracy and workflow.

Image Suite by Carestream Health Inc. is a radiological image processing system designed to assist clinicians in managing and analyzing medical images, enhancing diagnostic workflows.

Tempus Pixel is a software product that uses AI to automate the processing of radiological images, helping clinicians analyze medical scans more efficiently and accurately.

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.