BodyTom 64 (NL4100); OmniTom Elite (NL5000)
Samsung HME America, Inc., dba NeuroLogica Corp.The BodyTom 64 and OmniTom Elite are advanced CT scanners designed for both adults and children. They utilize a specialized image reconstruction algorithm (S-FBP) to produce clearer CT images with reduced artifacts and noise, making it easier for clinicians to visualize anatomy and detect health conditions such as lung cancer.
Intended Use
The BodyTom 64 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 and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast. BodyTom 64 system can be used for low dose lung cancer screening. The screening must be performed in compliance with the approved and established protocols as defined by professional medical societies. The OmniTom Elite computed tomography (CT) system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck. The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.
Technology
The primary technological change is a software update to the reconstruction algorithm, known as Weighted Filtered Back Projection (S-FBP), implemented in both devices. This algorithm improves image quality by reducing cone-beam and helical artifacts and enhances signal-to-noise ratio, with no changes to hardware. The system uses standard CT components (x-ray generator, detector array, moving gantry) and is battery powered for mobility.
Performance
Validation included bench (phantom) testing and a clinical study. Image quality metrics showed improvement: noise was reduced by ~29% and contrast-to-noise ratio improved by ~35% in BodyTom 64 (similar improvements for OmniTom Elite). Clinical evaluation by independent radiologists confirmed diagnostic image quality and effectiveness, with S-FBP reducing artifacts compared to previous FDK-based reconstruction.
Predicate Devices
No predicate devices specified
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