AIBOLIT 3D+
Aibolit Technologies, LLCAIBOLIT 3D+ is a web-based software system that processes CT and MR medical images to create detailed 2D and 3D visualizations of anatomical structures. It assists healthcare professionals in surgical planning, training, and intraoperative reference by turning multi-dimensional images into easy-to-view and manipulate anatomical models, with color-coded organ identification to improve clinical decision-making.
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 and MR imaging devices. It is also intended as software for preoperative surgical planning, training, patient information and for the intraoperative display of the multidimensional digital images. Designed for use by healthcare professionals to assist in making patient management decisions.
Technology
Software-only device that processes CT and MR DICOM images to create 3D images by manual radiologist segmentation followed by proprietary software-based organ identification and color-coding. Provides multi-axis rotation, zoom, transparency and organ hide/show functions. Web-based, allowing viewing on standard monitors and mobile devices.
Performance
Includes software verification and validation per FDA guidance with segmentation validation, repeatability and reproducibility studies, and accuracy studies of 3D model generation. AI-assisted segmentation uses a trained algorithm reviewed by radiologists to identify 108 anatomical structures. Validation showed conservation of shape, volume across organs and radiologists.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/15/2022
5 months - 2
FDA Approval
1/12/2023
Other devices from Aibolit Technologies, LLC
- AIBOLIT 3D+2022 • 510K
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