The BodyTom 64 is a computed tomography (CT) system designed for pediatric and adult imaging within an 85 cm aperture. It offers high-resolution CT scans with preset dose settings based on patient age and weight and can be used with or without contrast. The system is specifically intended for various diagnostic uses, including low dose lung cancer screening when used with established protocols. Its design includes a mobile gantry with a rotating disk x-ray generator and detector array, facilitating imaging at different clinical locations. The system includes an interventional radiology package that enhances clinical workflow and user experience.
Intended Use
The BodyTom 64 system is intended for X-ray computed tomography imaging of anatomy within an 85 cm aperture, for pediatric and adult patients, with preset dose settings based on weight and age. It can be used with or without contrast and supports low dose lung cancer screening under approved protocols.
Technology
A mobile, lightweight translating gantry CT system with a rotating disk x-ray generator, Gd2O2S detector array, collimator, data acquisition and reconstruction computers, battery power capability, and an interventional radiology software package. The system provides high-resolution, multi-row CT imaging with an 85 cm bore and 60 cm field of view. Software updates include enhanced user workflow and image quality improvements, especially for helical imaging.
Performance
The device underwent extensive verification and validation activities including software testing, electrical safety, electromagnetic compatibility, and image quality measurements using phantom tests. Image quality and radiation dose metrics demonstrated comparable performance to the predicate device. The software development and testing conformed to FDA guidance and IEC 62304 standards. Risk management processes and usability engineering were also followed to ensure safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/18/2024
5 months - 2
FDA Approval
3/14/2025
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