Ceevra Reveal 3+
Ceevra, Inc.Ceevra Reveal 3+ is a software medical device that processes 3D images from CT and MR scans, employing machine learning to generate segmentations of normal anatomy. It helps healthcare professionals in preoperative surgical planning and intraoperative visualization to improve patient management. The software runs on computers and mobile devices and provides interactive tools for clinicians to examine anatomical structures in detail.
Intended Use
Ceevra Reveal 3+ is intended as a medical imaging system that allows processing, review, analysis, communication, and media interchange of multi-dimensional digital images from CT or MR imaging devices, including generating preliminary segmentations of normal anatomy using machine learning and computer vision algorithms. It is also for preoperative surgical planning and intraoperative display, assisting clinicians in patient management decisions.
Technology
Ceevra Reveal 3+ is a software as a medical device that transforms CT and MR images into interactive 3D visualizations for preoperative and intraoperative use. It uses machine learning and computer vision algorithms to generate semi-automated segmentations of normal anatomy such as pulmonary arteries, veins, airways, and bronchopulmonary segments. Clinicians can interact via mobile or desktop applications with capabilities for rotation, zoom, measurements, and selective anatomy display.
Performance
The software validation included verification on 133 independent CT and MR imaging studies ensuring demographic and scanner diversity. Four machine learning models segment various structures (prostate, bladder, kidney, pulmonary arteries and veins, airways, bronchopulmonary segments) with Dice scores ranging from 0.82 to 0.93. Measurement features were validated on phantom and clinical imaging studies.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/20/2024
2 months - 2
FDA Approval
3/4/2025
Other devices from Ceevra, Inc.
- Ceevra Reveal 3+2023 • 510K
- Ceevra Reveal 32023 • 510K
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