PROView
GE Medical Systems SCSPROView 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.
Intended Use
PROView is an aiding tool for clinicians to review multi-parametric prostate magnetic resonance (MR) images following PI-RADS guidelines. It displays acquired and reformatted data for visualization and provides tools for assessment of the prostate gland volume and findings analysis in patients with known or suspected prostate lesions.
Technology
PROView provides a guided workflow for the review, assessment, and reporting of multi-parametric MR prostate exams, featuring automatic prostate gland segmentation using a deep learning model, lesion measurement and scoring, and report generation following PI-RADS v2.1 guidelines.
Performance
PROView completed design control testing, risk analysis, design reviews, software verification, safety testing, and algorithm validation using a representative MRI prostate exam database, demonstrating improved performance on volume accuracy with results meeting acceptance criteria.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/29/2019
11 months - 2
FDA Approval
11/17/2020
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