FDA Radiology AI Devices

The GT300 and GT300-C are dental computed tomography (CT) devices used in radiology to produce detailed X-ray images of the teeth and jaw. These devices assist clinicians in diagnosing and planning treatment by providing high-resolution images of dental structures.

The Bunkerhill MAC is a computed tomography system that uses X-rays to produce detailed images of the body's internal structures. This device assists clinicians by providing high-resolution tomographic images to aid in diagnosis and treatment planning.

LungQ 4 is a computed tomography-based medical imaging product designed to assist clinicians in analyzing lung images. It provides AI-driven insights that help in the detection and assessment of lung conditions, improving diagnostic accuracy and patient management in radiology departments.

The Self-Propelled CT Scan Base Kit, combined with the Alphenix system and its software, provides advanced computed tomography imaging capabilities. It helps clinicians capture detailed cross-sectional images of patients to assist in diagnosis and treatment planning.

Ligence Heart is an AI-driven software designed to automatically process radiological images for cardiac assessment. It helps clinicians by providing automated analysis of heart images, potentially improving diagnostic efficiency and accuracy.

Rapid Aortic Measurements is an AI-powered software product designed to automatically process radiological images to assist clinicians in measuring aortic structures quickly and accurately.

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

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.

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.

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.