Biograph Trinion

The Biograph Trinion is a combined PET/CT imaging system that integrates positron emission tomography and computed tomography to provide fused metabolic and anatomic images. It is intended for detecting, diagnosing, staging, and restaging lesions, tumors, and diseases in oncology, neurology, and cardiology, and can be used for low-dose lung cancer screening in high-risk populations.

The Biograph Trinion VK20 incorporates SOMATOM go.All and go.Top CT systems with VB10 software into the PET/CT platform, adds additional PET axial field-of-view options for scalability, includes enhanced patient communication and comfort features, and implements PET respiratory gating with an external gating device. No changes affect the fundamental CT technology or PET detection methodology.

PET testing per NEMA NU 2: 2024 covering spatial resolution, scatter fraction, count losses, randoms, sensitivity, accuracy of corrections, image quality, time-of-flight resolution, and PET-CT coregistration. Compliance claimed with IEC 60601 series (electrical safety), IEC 60601-2-28 and 2-44 (imaging devices), IEC 61223-3-5 (CT), ISO 10993-1 (biocompatibility), ISO 14971 (risk management), and ISO 13485 (quality management).

The device performs identically to or better than the predicate Biograph Trinion VK10 on all NEMA NU 2 performance tests, with no changes to indications for use or fundamental technology. The differences are incremental enhancements (upgraded CT software, additional PET FoV options, comfort features, respiratory gating) that do not alter the core diagnostic function or safety profile, maintaining substantial equivalence to the predicate device.