FDA Radiology AI Devices

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.

VistaSoft 4.0 and VisionX 4.0 are automated software tools designed to assist clinicians by processing radiological images. They help improve image interpretation to support diagnostic decisions in medical imaging.

Rapid DeltaFuse by iSchemaView Inc. is an image processing system designed for radiological applications. It helps clinicians by efficiently processing and analyzing medical images to support diagnostic decisions.

GBrain MRI by Galileo CDS, Inc is an AI-powered software designed to process MRI images automatically, helping radiologists interpret brain scans more efficiently.

Vista OS, Vista AI Scan, and RTHawk are AI-based systems designed to work with MRI imaging. These systems help clinicians acquire and process MRI scans more efficiently, potentially improving imaging quality and reducing scan time to assist diagnosis and patient care.

RiasDR is a software product designed to acquire and process digital radiographic images, helping clinicians by efficiently managing and enhancing X-ray images for diagnosis and treatment planning.

The INNOVISION-DXII is a stationary X-Ray system used in radiology to capture high-quality X-ray images. It helps clinicians by providing reliable imaging for diagnosing various conditions, facilitating accurate patient assessment and treatment planning.

The Biograph Trinion is a combined PET/CT imaging system designed to provide high-resolution fusion of metabolic and anatomical information. It assists healthcare professionals in detecting, diagnosing, staging, and managing diseases such as cancer, cardiovascular disorders, and neurological conditions. The system also supports radiotherapy planning and interventional procedures, enhancing diagnostic accuracy and patient care.

YSIO X.pree is a modular digital X-ray system designed to visualize anatomical structures across the whole body, including the skull, chest, abdomen, and extremities. It helps clinicians by producing high-quality X-ray images that support diagnosis and therapy decisions. The system features updated hardware and software, including a new wireless detector and AI-based auto-cropping and collimation capabilities, enhancing workflow efficiency and image quality.

The REMEX Xcam6 is a portable, handheld mobile X-ray system designed for hospital or clinic use to capture diagnostic X-ray images of patient extremities. It can be used with a flat panel detector to acquire, display, and manipulate images. It enables clinicians to obtain high-quality radiographic images conveniently and safely, aiding the diagnosis of various conditions affecting extremities.