FDA Radiology AI Devices

The Cartesion Prime (PCD-1000A/3) V10.15 is a PET/CT emission computed tomography system designed for diagnostic imaging. It helps clinicians by producing high-quality fused metabolic and anatomical images through PET and CT scans, improved by AI-driven noise reduction and motion correction. This aids in the evaluation, diagnosis, and treatment planning of various diseases such as cancer, cardiovascular and neurological disorders.

DeepXray is an AI-powered software that helps medical professionals analyze knee X-rays by automatically measuring joint space width and assessing signs of osteoarthritis such as sclerosis, joint space narrowing, and osteophytes. It supports clinicians by providing detailed grading based on established radiographic criteria and offers an interactive report for review and editing before finalizing.

The MAGNETOM Viato.Mobile by Siemens is a 1.5 Tesla mobile MRI system designed to be relocated to different locations where imaging services are needed. It produces high-quality MR images of the head, body, and extremities in multiple planes and can also be used during interventional procedures. This helps clinicians diagnose a variety of conditions by providing detailed internal anatomical and functional imaging.

The Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR is a 3 Tesla MRI system developed by Canon Medical Systems Corporation. It produces detailed cross-sectional images of the body and head using advanced AI-powered reconstruction techniques to enhance image quality, reduce artifacts, and improve workflow for clinicians. The device supports various deep learning-based features for motion correction, image resolution enhancement, noise reduction, and automated scan protocols, aiding diagnosis and patient care.

VisAble.IO is a software tool that helps doctors plan and confirm liver ablation procedures using CT images. It provides features like segmentation of liver structures, virtual placement of ablation needles, and analysis of ablation zones to support clinicians during treatment. It is designed to improve the accuracy and efficiency of liver ablation therapy planning and evaluation in clinical settings.

AIRAscore is an AI-powered software that automates the identification, labeling, and volumetric measurement of brain structures from MRI scans. It helps clinicians quickly obtain detailed brain volume information, which can aid in diagnosis and monitoring of neurological conditions by providing consistent and accurate brain segmentation results.

qXR-PTX-PE is an AI-powered software that assists radiologists by automatically analyzing adult chest X-rays to detect signs of pleural effusion and pneumothorax. It helps prioritize cases by providing case-level outputs within the existing PACS/workstation without altering images or providing direct clinical diagnosis, thereby improving workflow efficiency.

Annalise Enterprise CTB Triage-OH is an AI-powered software tool designed to help clinicians prioritize brain CT scans by detecting features suggestive of obstructive hydrocephalus. It integrates with hospital imaging and order management systems to flag and prioritize suspicious cases, enabling faster review and improving clinical workflow without replacing clinical decision-making.

VisiRad XR is an AI-powered software that helps physicians detect suspicious lung nodules and masses on chest X-rays by marking regions of interest. It acts as a second reader to assist radiologists in their interpretations, enhancing diagnostic accuracy for adult patients in outpatient or emergency settings.

The Rapid Aneurysm Triage and Notification device by iSchemaView Inc. is an AI-powered software designed to analyze CT angiography images of the head to detect suspected saccular aneurysms. It helps hospital networks and radiologists by prioritizing cases with potential aneurysms for faster review, improving workflow in routine patient care. The software provides notifications and compressed preview images for informational use, supporting radiologists in triage but not intended for diagnosis.