BodyTom Elite (NL4000)
NeuroLogica Corp., a Samsung CompanyThe BodyTom Elite (NL4000) is a portable CT scanner designed to image various anatomical regions in both adults and children. It helps clinicians obtain detailed cross-sectional images for diagnosis and management, including use cases such as lung cancer screening.
Intended Use
The BodyTom Elite system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture. The CT system is intended to be used for both pediatric and adult imaging with preset dose settings based upon weight and age. The CT images can be obtained with or without contrast. BodyTom Elite system can be used for low dose lung cancer screening in compliance with established protocols.
Technology
The BodyTom Elite is a high-resolution, multi-row CT scanner with an 85 cm bore and 60 cm field of view. It contains a rotating gantry with a solid-state x-ray generator, detector array, collimator, and an advanced reconstruction computer. The key update from its predicate is a new Linux-based operating system for reconstruction, with all other major hardware components unchanged.
Performance
Comprehensive verification and validation testing including: software verification and validation, bench testing for image quality (noise, contrast, slice thickness, etc.), and safety standards compliance (electrical, EMC, radiation). Performance was shown to meet or exceed the predicate device with no new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
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