Biograph Vision.X and Biograph Vision.X Edge
Siemens Medical Solutions USA, Inc.The Biograph Vision.X and Biograph Vision.X Edge are advanced combined PET and CT scanners that provide high-resolution images by fusing metabolic and anatomical information. These systems assist healthcare professionals in detecting, diagnosing, and monitoring diseases such as cancer, cardiovascular and neurological disorders, and support treatment planning and interventional procedures.
Intended Use
Combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners to provide registration and fusion of physiologic and anatomic information for detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease, and organ function in diseases such as cardiovascular disease, neurological disorders, and cancer; also aids in radiotherapy and interventional radiology planning.
Technology
The PET/CT system integrates multi-slice X-Ray CT and PET scanners to produce fused metabolic and anatomical images. It includes updated PET detector electronics for improved time-of-flight resolution and software for patient and data management, scan control, image reconstruction, archiving and evaluation complying with DICOM standards.
Performance
The device underwent NEMA NU2-2018 PET performance testing, showing that all resolution, sensitivity, count rate, scatter fraction, co-registration accuracy, time of flight resolution, and contrast/background variability parameters passed acceptance criteria. CT subsystem performance testing was included in a prior submission with no changes affecting it. Cybersecurity controls are incorporated to protect against unauthorized access and use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/22/2023
21 days - 2
FDA Approval
7/13/2023
Other devices from Siemens Medical Solutions USA, Inc.
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