Bone VCAR (BVCAR)
GE Medical Systems SCSBone VCAR is a software tool designed to assist clinicians in reviewing CT images that include the spine. It uses deep learning to automatically label vertebrae and provides optimized display settings to improve visualization and reporting efficiency across multiple care areas such as trauma and oncology.
Intended Use
Bone VCAR is a post processing application for use in the analysis of CT images. It supports clinicians in reviewing spine images by labeling vertebrae and optimizing anatomical display to facilitate faster and easier image review and reporting.
Technology
Bone VCAR uses a deep learning technique to automatically identify and label vertebrae in CT scans. It offers multiple multiplanar reconstruction display modes and allows manual editing of anatomical labels. It is compatible with single energy and Gemstone Spectral Imaging CT acquisitions.
Performance
The algorithm demonstrated over 90% success rate in automatic vertebrae labeling validated on a clinical dataset representing various acquisition parameters and pathologies. Clinical evaluation with three radiologists showed it improved labeling speed and reporting efficiency compared to manual labeling. The device underwent design control and quality system testing per 21 CFR 820 and ISO 13485 standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/19/2018
4 months - 2
FDA Approval
4/8/2019
Other devices from GE Medical Systems SCS
- CardIQ Suite2024 • 510K
- Spine Auto Views2023 • 510K
- FlightPlan for Embolization2023 • 510K
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