FDA Radiology AI Devices

InVision Precision LVEF is a software tool that analyzes previously acquired transthoracic cardiac ultrasound images to automatically estimate the left ventricular ejection fraction, helping clinicians with cardiac evaluation. The software processes DICOM ultrasound videos, uses machine learning to segment the left ventricle, and allows clinicians to review and adjust the measurements for precise cardiac function assessment.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced ultrasound imaging devices that include innovative AI-powered software features. The Smart View Select software automatically selects optimal heart images for analysis, while the Segmental Wall Motion software evaluates the movement of specific regions of the heart's left ventricle. These tools help clinicians perform more efficient and precise cardiac assessments, enhancing diagnosis and treatment planning.

ART-Plan (v.2.2.0) is a medical software platform designed to help clinicians involved in radiotherapy for cancer patients. It allows users to contour regions of interest on 3D images, perform image registration and fusion from multiple imaging modalities (CT, MRI, CBCT), generate synthetic CT images using deep learning, and support decision-making for treatment replanning. This assists medical professionals in precisely targeting radiation therapy and adapting treatment based on daily patient imaging data, improving safety and treatment efficacy for cancer patients aged 18 and above.

Rapid by iSchemaView Inc. is a medical image processing software designed to help clinicians analyze CT and MRI images, including functional and dynamic datasets like CT Perfusion and diffusion-weighted MRI. It facilitates quick visualization, quantification, and interpretation of brain tissue changes often seen in acute stroke, helping physicians select patients for endovascular thrombectomy and assess cerebral hemodynamics. The software supports both standard and C-arm CT images and assists in managing complex imaging data efficiently, enhancing clinical workflow and patient care in neurological emergencies.

uOmnispace.MR is advanced software developed by Shanghai United Imaging Healthcare Co., Ltd. that helps clinicians view, process, and analyze magnetic resonance (MR) images across various clinical applications such as brain, breast, cardiac, vascular, and neurological imaging. It supports interpretation and evaluation by providing tools for stitching, dynamic studies, spectroscopy, perfusion, vessel analysis, cardiac function analysis, and flow analysis, enabling improved diagnostic workflows and patient care.

VisAble.IO is a software tool that helps physicians plan and evaluate liver ablation treatments by processing CT and MRI images. It assists in identifying treatment targets, planning needle placement virtually, and confirming the treatment area post-procedure to improve procedure accuracy and patient outcomes.

The Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 is a 1.5 Tesla magnetic resonance imaging (MRI) system developed by Canon Medical Systems. It incorporates AI-based technologies in its reconstruction processing unit (AiCE) to improve image quality, reduce scan time, and assist operators. This system aids clinicians by producing high-resolution images of anatomical structures of the head and body, facilitating accurate diagnosis and efficient workflow.

True Enhance DL is a deep learning-based software from GE Healthcare Japan Corporation that enhances contrast in standard 120 kVp CT images of the body, making details clearer without requiring changes to acquisition parameters. It is intended to assist clinicians by providing improved image contrast to aid diagnosis and is suitable for patients of all ages.

The uMR 680 is a 1.5T superconducting magnetic resonance imaging device that produces detailed anatomical and functional images to assist physicians in diagnosis. It includes components such as magnets, RF coils, and software for imaging the head, body, and extremities, helping clinicians with diagnostic imaging using MRI technology.

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is an AI-powered software that automatically analyzes CT angiography scans of the chest region to detect signs of acute aortic syndrome, including aortic dissection and intramural hematoma. It helps radiologists prioritize and triage cases by flagging suspicious studies, enabling faster diagnosis and improved workflow efficiency, although it is not a substitute for clinical decision-making.