FDA Radiology AI Devices

Acorn 3D Software and Acorn 3DP Model are image processing solutions used in radiology to analyze medical images and potentially create 3D models, helping clinicians better visualize anatomical structures for diagnosis and treatment planning.

The ZAP-X Radiosurgery System is a medical device that uses a linear accelerator to deliver precise radiation therapy to treat conditions, often tumors, with high accuracy. This technology assists clinicians by focusing radiation while sparing surrounding healthy tissue, improving patient outcomes.

The Sonosite MT Ultrasound System is an advanced ultrasound imaging device that uses pulsed Doppler technology to help clinicians capture real-time images and blood flow information, aiding in diagnosis and treatment planning.

The Aplio i900, i800, and i700 Software V9.0 are diagnostic ultrasound systems used for medical imaging. These systems help clinicians visualize internal body structures in real-time using pulsed Doppler ultrasound technology, aiding in diagnosis and treatment planning.

AiORTA - Plan is an AI-powered software that processes radiological images automatically, assisting clinicians by enhancing image analysis workflows in radiology. It helps improve accuracy and efficiency in interpreting medical images.

The LOGIQ E10 is an advanced ultrasound imaging system developed by GE Medical Systems. It uses pulsed Doppler ultrasonic technology to produce detailed real-time images, helping clinicians accurately assess and diagnose patients through non-invasive ultrasound scans.

LOGIQ E10s is an advanced ultrasound imaging system by GE Medical Systems that uses pulsed Doppler technology to produce detailed medical images. It helps clinicians in diagnosing and monitoring patients by providing real-time visualization of internal body structures and blood flow.

The Visions® PV .014P RX and .018 Digital IVUS Catheters are ultrasound devices used inside blood vessels to generate detailed images of the vessel walls. These imaging tools help clinicians diagnose and treat cardiovascular diseases by providing real-time internal views, improving decision-making and patient care.

TheraSphere 360™ Y-90 Management Platform is a radiological image processing system designed to assist clinicians in managing Yttrium-90 therapy treatments. It aids in visualizing and planning therapy using processed medical images, helping clinicians optimize patient outcomes.

The cvi42 Coronary Plaque Software Application is a medical software tool that assists physicians in analyzing coronary CT angiography images. It uses AI and machine learning algorithms to help detect and quantify the presence and extent of coronary plaques and stenoses in patients, providing measurements and visualization to aid diagnostic decision-making for coronary artery disease evaluation.