AIBOLIT 3D+
AIbolit Technologies, LLCAIBOLIT 3D+ is a software system that takes CT scan images and processes them into detailed 3D visual models of anatomical structures. This tool helps doctors plan surgeries, train, and educate patients by enabling interactive viewing of organs and tissues from multiple angles and with enhanced clarity. It supports better decision-making and may reduce errors during procedures.
Intended Use
Aibolit 3D+ 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 imaging devices. It is also intended as software for preoperative surgical planning, training, patient information and as software for the intraoperative display of the multidimensional digital images. It is designed for use by health care professionals and intended to assist the clinician who is responsible for making all final patient management decisions.
Technology
Aibolit 3D+ is a web-based stand-alone software application that processes CT images to create 3D images allowing multi-axis rotation, organ segmentation, transparency, and labeling. It uses proprietary software to assign color coding and display anatomical structures, facilitating surgical planning and intraoperative reference.
Performance
The device underwent software validation, risk analysis, usability evaluation, and cybersecurity assessments. It was demonstrated substantially equivalent to the predicate device Ceevra Reveal 2.0 in terms of intended use, principle of operation, technology, and performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/10/2021
8 months - 2
FDA Approval
1/7/2022
Other devices from AIbolit Technologies, LLC
- AIBOLIT 3D+2023 • 510K
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