BodyTom 64

The BodyTom 64 is a computed tomography (CT) x-ray system designed for imaging anatomy that fits within an 85 cm aperture. It is intended for both pediatric and adult imaging with preset dose settings based on weight and age, and can be used for low-dose lung cancer screening in compliance with established clinical protocols.

The BodyTom 64 is identical in design, materials, and basic functionality to its predicate device (K213649). The main difference is the addition of an interventional radiology software package (which is the same as the reference device BodyTom Elite K170238) plus a new Instant Repeat feature. Hardware components remain unchanged, including the x-ray generator, collimator, slip ring, and power system.

The device conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-44, IEC 60601-1-3, IEC 60601-1-6, IEC 62304, ISO 14971, NEMA XR 25/26/28/29, and 21 CFR §1020.30 and §1020.33. Image quality testing followed FDA equipment performance standards for diagnostic x-ray systems, measuring noise, slice thickness, contrast resolution, and modulation transfer function using phantom tests.

The subject and predicate devices have identical CT system design, bore diameter (85 cm), field of view (60 cm), and core hardware components. The software updates (interventional radiology package and Instant Repeat feature) are non-hardware modifications that enhance user experience without changing fundamental functionality. Performance testing demonstrated comparable image quality metrics and confirmed that the new features did not negatively impact device specifications or raise new safety or effectiveness concerns, establishing substantial equivalence.