Ceevra Reveal 3+
Ceevra, Inc.Ceevra Reveal 3+ is a software medical imaging system that processes CT and MRI scans to generate detailed three-dimensional images. It uses machine learning algorithms to assist clinicians in segmenting and visualizing normal anatomy to support preoperative surgical planning and intraoperative display. This helps healthcare professionals better review, analyze, and plan treatment by interacting with 3D images on computers, mobile devices, or VR headsets.
Intended Use
Ceevra Reveal 3+ is a medical imaging system that processes, reviews, analyzes, communicates, and interchanges multi-dimensional digital images from CT or MR imaging. It employs software with machine learning and computer vision algorithms for preliminary segmentation of normal anatomy, supports preoperative planning, and intraoperative display for healthcare professionals.
Technology
Ceevra Reveal 3+ is software as a medical device that generates 3D images from CT and MR scans. It features interactive display tools including rotation, zooming, and selective viewing on mobile devices, desktop computers, external displays, or VR headsets. Machine learning models perform segmentation of normal anatomical structures. The device calculates volumes, diameters, and distances, verified against phantom and clinical datasets. Software validation followed IEC 62304 and FDA guidance documents.
Performance
Performance was verified using clinical CT and MR datasets from diverse patient populations and scanner manufacturers, with 141 imaging studies used for evaluation. The machine learning segmentation models were benchmarked with Sørensen–Dice coefficient and Hausdorff distance metrics, showing high performance for multiple anatomical structures (e.g., prostate DSC 0.87, bladder DSC 0.90). Measurement features were validated for accuracy within ±10%.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/6/2023
29 days - 2
FDA Approval
12/5/2023
Other devices from Ceevra, Inc.
- Ceevra Reveal 32023 • 510K
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