FDA Radiology AI Devices

AView LCS by Coreline Soft Co., Ltd. is a medical software tool that helps clinicians review, analyze, and report on thoracic CT scans. It automatically detects and measures lung nodules, calculates malignancy risk, supports follow-ups with nodule matching, and generates diagnostic reports. This improves the accuracy and efficiency of lung nodule assessment and lung cancer screening.

The SIGNA 7.0T is a high-performance whole-body MRI scanner designed by GE Healthcare to produce high-resolution images of the head and extremities. It supports multiple imaging techniques and pulse sequences to generate detailed anatomical, functional, spectroscopic, and vascular images. The device helps clinicians in diagnosis by delivering high signal-to-noise ratio images with shorter scan times, particularly enabled by its advanced 7.0 Tesla magnetic field strength and optimized hardware.

Quantib Prostate is advanced image post-processing software designed to assist trained medical professionals in analyzing prostate MRI scans. It provides tools for automatic and semi-automatic segmentation of the prostate, visualization of multiparametric MRI images, PI-RADS scoring, and lesion analysis. By combining multiple MRI sequences into a single view and supporting volume computations, it helps clinicians in the detailed interpretation of prostate imaging, potentially improving diagnostic accuracy.

LiverMultiScan (LMSv4) is a standalone software device that assists clinicians by processing MR images of the liver to provide quantitative maps and measurements that help characterize liver tissue health. It automates segmentation and analysis of MRI data to produce reports for trained clinicians to interpret as part of liver disease diagnosis and assessment.

Cleerly Labs v2.0 is a web-based software that assists trained medical professionals by analyzing coronary CT images to detect atherosclerosis and stenosis. It uses AI to segment and label coronary arteries, enhancing efficiency and accuracy in diagnosing coronary artery disease and supporting clinical decision making.

THINQ is a medical imaging software device designed to automatically segment, label, and measure volumes of brain structures from 3D T1-weighted MRI scans. It provides clinicians with visual and quantitative reports comparing brain volumes to reference data, helping in the assessment of neurological conditions by automating brain morphometry.

LVivo Seamless is an AI software application that automatically analyzes echocardiogram ultrasound images to assess cardiac function by calculating parameters like ejection fraction (EF). It helps clinicians by streamlining the evaluation process, sending analyzed results directly to PACS for review, enhancing diagnostic efficiency and accuracy for patients with suspected cardiac disease.

Xeleris V Processing and Review System is a nuclear medicine software platform that helps physicians process, review, and quantify medical images from nuclear medicine, PET, and associated CT or MR scans. It supports multiple clinical applications including detection of brain diseases, lung conditions, coronary artery disease, and bone metastases, using AI-based image analysis such as deep learning for automated segmentation to enhance workflow efficiency and accuracy.

EchoPAC Software Only / EchoPAC Plug-in is a diagnostic ultrasound image analysis software by GE that enables physicians to view, post-process, measure, and analyze ultrasound images across many clinical applications including cardiac, fetal, abdominal, musculoskeletal, and vascular imaging. It incorporates AI-based features to semi-automate cardiac measurements and streamline image interpretation, helping clinicians obtain quantitative data more efficiently and accurately.

Caption Guidance is an AI-powered software accessory designed to assist medical professionals in acquiring high-quality cardiac ultrasound images. It provides real-time feedback and guidance to help users obtain standard echocardiographic views, improving image quality and diagnostic accuracy.