FDA Radiology AI Devices

AI-Rad Companion Prostate MR is a software tool designed to assist radiologists by processing prostate MR images using artificial intelligence, helping improve detection and diagnosis of prostate-related conditions.

Hybrid Viewer by Hermes Medical Solutions AB is a software system designed to support medical imaging in computed emission tomography, helping clinicians view and analyze tomographic images for diagnostic purposes.

Segmentron Viewer is an automated software tool designed for processing radiological images to assist clinicians by improving image analysis and interpretation for medical purposes.

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.