CT Rembra RT; CT Areta RT; CT Rembra

The CT Rembra RT, CT Areta RT, and CT Rembra are computed tomography X-ray systems that produce cross-sectional images of the head and body by computer reconstruction of X-ray transmission data. They are indicated for diagnostic imaging in radiology, oncology (treatment planning and radiation therapy), vascular, interventional, neurology, and cardiology applications, as well as low-dose lung cancer screening, for patients of all ages.

The proposed devices are whole-body CT systems with continuous rotation, single-layer detector architecture, an 85 cm bore, 60 cm scan field of view, and up to 85 cm extended field of view. They feature the updated Incisive Host software platform with enhanced oncology and radiotherapy planning workflows. Key modifications include improved detector elements, enhanced image resolution, pulmonary gating (4D CT), body perfusion, and new software features (MM Sim auto-launch, CANOpen injection) compared to the predicate CT 5300.

Compliance demonstrated with AAMI/ANSI ES60601-1:2005, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-44, IEC 62304, IEC 62366-1, ISO 14971, ISO 10993-1, NEMA XR 25, NEMA XR 26, NEMA XR 28, and NEMA XR 29. Non-clinical testing included system and subsystem verification, phantom testing, cybersecurity assessment, usability evaluation, and external image quality review.

The proposed devices have the same fundamental technological characteristics, intended use, and indications as the predicate devices (CT 5300, Philips CT Big Bore, Spectral CT 7500 RT). Hardware and software modifications are supported by non-clinical performance testing and do not raise new questions of safety and effectiveness. All differences are either comparable to predicate features or supported by verification and validation testing demonstrating acceptable performance for the intended clinical applications.