Biograph Trinion
Siemens Medical Solutions USA, Inc.The Biograph Trinion is a combined PET/CT imaging system designed to provide high-resolution fusion of metabolic and anatomical information. It assists healthcare professionals in detecting, diagnosing, staging, and managing diseases such as cancer, cardiovascular disorders, and neurological conditions. The system also supports radiotherapy planning and interventional procedures, enhancing diagnostic accuracy and patient care.
Intended Use
The Siemens PET/CT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. They are intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for evaluation of various diseases and disorders including cardiovascular disease, neurological disorders and cancer.
Technology
The Biograph Trinion PET/CT systems consist of combined multi-slice CT and PET scanners with a patient handling system, acquisition and processing workstations. The system uses the Biograph Trinion VK20 software for patient and data management, scan control, and image reconstruction. It maintains independent CT and PET functionality, generating DICOM-compliant images.
Performance
Performance testing followed NEMA NU 2: 2024 standards, including spatial resolution, sensitivity, image quality, and PET-CT coregistration accuracy, all meeting or exceeding predicate device acceptance values. Risk management complies with ISO 14971 and other relevant standards. The device includes cybersecurity controls to safeguard against unauthorized access and misuse.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/21/2025
2 months - 2
FDA Approval
7/31/2025
Other devices from Siemens Medical Solutions USA, Inc.
- Cios Spin2025 • 510K
- Cios Alpha; Cios Flow2025 • 510K
- Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems2025 • 510K
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