Biograph Vision, Biograph mCT Family of PET/CTs
Siemens Medical Solutions USA, IncThe Biograph Vision and Biograph mCT PET/CT systems from Siemens are advanced imaging machines that combine CT and PET technologies to produce high-resolution images showing both anatomical structures and physiological functions. These systems help healthcare professionals detect, localize, diagnose, and stage various diseases including cancer, cardiovascular, and neurological disorders, and also assist with radiotherapy and interventional procedures.
Intended Use
The Siemens Biograph Vision and Biograph mCT 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. The systems produce cross-sectional CT images and PET images to determine metabolic and physiologic functions in humans.
Technology
The systems combine multi-slice X-ray CT and PET scanners, providing registration and fusion of metabolic and anatomical information. They include patient handling systems, acquisition, and processing workstations with DICOM compliant software. The software supports patient and data management, scan control, image reconstruction, and archival. New features include OncoFreeze AI for data driven gating, FlowMotion AI for PET fast planning, and whole body scatter correction.
Performance
Performance testing was conducted according to NEMA NU2-2018 standards for PET and includes resolution, sensitivity, count rates, image quality, and co-registration accuracy. Specific scientific evaluations were performed for the AI components OncoFreeze AI, FlowMotion AI, and whole body scatter correction, demonstrating equivalent or improved performance. The device complies with relevant IEC and ISO standards, and includes cybersecurity controls to protect against unauthorized access and misuse.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/25/2019
2 months - 2
FDA Approval
2/14/2020
Other devices from Siemens Medical Solutions USA, Inc
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