Ceevra Reveal 3
Ceevra, Inc.Ceevra Reveal 3 is a software medical device designed for processing, reviewing, and analyzing 3D images created from CT and MR scans. It helps clinicians with preoperative surgical planning and intraoperative image display, including interacting with 3D visualizations using mobile or desktop viewers, and even VR headsets. By using AI-driven algorithms, it generates preliminary segmentations of normal anatomical structures to assist healthcare professionals in their clinical decisions for adult patients.
Intended Use
Ceevra Reveal 3 is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices, including generation of preliminary segmentations of normal anatomy using machine learning and other computer vision algorithms. It is also intended for preoperative surgical planning and intraoperative display of these images. Designed for use by healthcare professionals to assist clinical decision making.
Technology
Ceevra Reveal 3 is software as a medical device that processes existing 3D patient images from CT and MR scans using machine learning models to generate segmentations of normal anatomical structures. It offers interactive 3D visualization features such as rotation, zooming, panning, and selective visibility of structures, and supports viewing on mobile devices, desktop, external displays, and VR headsets. The software incorporates four machine learning models that have been validated on diverse patient and scanner datasets.
Performance
The performance of Ceevra Reveal 3 was validated using 141 imaging studies across diverse populations and scanner manufacturers. Its machine learning models were tested independently of training data and showed good segmentation accuracy for normal anatomical structures such as prostate, bladder, neurovascular bundles, kidney, arteries, and veins, measured by metrics including Sørensen–Dice coefficient and Hausdorff Distance, conforming to relevant software lifecycle and FDA guidance standards for medical device software.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/6/2022
7 months - 2
FDA Approval
4/25/2023
Other devices from Ceevra, Inc.
- Ceevra Reveal 3+2023 • 510K
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