Ezra Plexo Software
Ezra AI Inc.Ezra Plexo Software is a medical imaging application designed to help radiologists view, manipulate, and compare 2D and 3D MR images through a web browser. It supports oncological workflows by enabling visualization, evaluation, quantification, and documentation of lesions, facilitating better clinical assessment and decision-making.
Intended Use
Ezra Plexo Software is a medical diagnostic application for viewing, manipulation, 3D-visualization, and comparison of MR medical images. It supports visualization of information that would otherwise be compared disjointedly and helps confirm the absence or presence of lesions, including evaluation, quantification, and documentation of such lesions.
Technology
Ezra Plexo Software is an application accessed via web browser for 2D and 3D visualization, comparison, and manipulation of medical MR images. It allows volumetric segmentation, editing of segmentations, and quantitative measurements. It uploads previously acquired data files, independent of acquisition equipment vendor, and presents analysis results on screen for review.
Performance
The software was tested with 150 patient exams using consensus ground truth from five board-certified expert radiologists, demonstrating that it performs its intended use effectively and is clinically acceptable without introducing new safety or efficacy concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/23/2019
8 months - 2
FDA Approval
7/10/2020
Other devices from Ezra AI Inc.
- Ezra Flash2023 • 510K
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