FDA Radiology AI Devices

Quantib Prostate is a software tool that helps medical professionals analyze prostate MRI images. It automatically segments the prostate and its subregions, supports visualization with multiparametric MRI, and assists in identifying and editing potential lesions. By streamlining these tasks, it aids radiologists in interpreting prostate MRI studies more efficiently and effectively.

Quantib Prostate is an AI-powered image post-processing software designed to assist medical professionals in analyzing prostate MRI scans. It provides tools for visualization, semi-automatic segmentation of prostate anatomy and lesions, volume computations, and PI-RADS scoring support to facilitate the interpretation of prostate MR studies, aiding clinical decision-making.

aPROMISE X is a software platform for healthcare professionals and researchers that assists in accepting, transferring, storing, manipulating, quantifying, and reporting digital medical images from PSMA PET/CT scans. It allows users to visualize multiple scans, mark regions of interest, and perform quantitative analysis to help identify suspicious lesions in oncology cases, improving clinical efficiency and consistency.

QUIBIM Precision Prostate (qp-Prostate) is software designed to assist trained professionals such as radiologists in viewing and analyzing prostate MRI scans. It offers advanced post-processing features to quantify diffusion and perfusion characteristics, helping clinicians better visualize prostate tissue and complete structured reports. This software enables improved image analysis and decision support without performing a direct diagnostic function.

PROView is a software tool designed to help clinicians review and analyze prostate MRI scans by automatically segmenting the prostate gland and assessing lesions using AI-based deep learning techniques. It supports the evaluation of prostate lesions according to PI-RADS guidelines, providing measurements, scoring, and reporting functionalities to assist in diagnosis and treatment planning for prostate conditions.

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.

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.