FDA Radiology AI Devices

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.