FDA Radiology AI Devices

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.

The EVIS EUS Ultrasound Gastrointestinal Videoscope by Olympus is an advanced endoscopic ultrasound device that allows physicians to visualize the gastrointestinal tract using ultrasound technology. This helps clinicians diagnose and assess gastrointestinal conditions more accurately by combining endoscopy with ultrasound imaging.

HPACS is an image processing system designed for radiology that helps clinicians by enhancing and managing medical images, potentially improving diagnosis and workflow efficiency.

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.

Philips IntelliSpace Cardiovascular is a medical image processing system designed to assist clinicians in analyzing cardiovascular images. It facilitates improved visualization and assessment of heart-related conditions to support patient diagnosis and treatment planning.

The Shear Wave Quantificational Ultrasound Diagnostic System is an advanced ultrasound machine that uses shear wave technology to provide quantitative assessment of tissue stiffness. This helps clinicians evaluate various conditions by producing detailed images and measurements, improving diagnosis and treatment planning.

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.

The Optima Coil System is a medical device used in neurovascular procedures to embolize, or block, blood vessels in the brain. This helps treat conditions such as brain aneurysms or vascular malformations by preventing blood flow to problematic areas, supporting clinicians in preventing strokes or hemorrhages.

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.

The EMBOTRAP III Revascularization Device is a specialized catheter used to remove blood clots from vessels in the brain, helping to restore blood flow in patients with ischemic stroke. It assists clinicians in performing minimally invasive procedures that can improve outcomes for stroke patients by clearing vessel blockages.