Lung Vision
BODY VISION MEDICAL LTD.The LungVision System is a medical imaging software that helps doctors navigate tools inside the lungs during procedures. It works by segmenting CT scan data and overlaying it on live X-ray images to guide catheter placement accurately, improving procedural safety and effectiveness.
Intended Use
The LungVision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.
Technology
PC-based software that segments DICOM 3D CT images, registers them with live fluoroscopy, and overlays segmented data on live X-ray images for navigation. Runs on Windows OS with image enhancement and navigation visualization capabilities.
Performance
Bench testing confirmed the device met all requirements and was equivalent to the predicate device. Testing included verification of system requirements, hazard mitigation, system performance, and accuracy testing on pig lungs. Compliance with IEC standards was demonstrated. No clinical testing was performed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/22/2016
4 months - 2
FDA Approval
5/11/2017
Other devices from BODY VISION MEDICAL LTD.
- Lung Vision System2019 • 510K
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