Intended Use

The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of physiologic and anatomic information. The system aids in detecting, localizing, diagnosing, staging, and restaging lesions, tumors, disease, and organ function for diseases and disorders including cardiovascular disease, neurological disorders, and cancer.

Technology

The Biograph VK10 is a scalable combined PET/CT system featuring an air-cooled Silicon Photomultiplier (SiPM) PET system and updated CT subsystem from commercially available Siemens CT scanners, providing high resolution metabolic and anatomic registration and fusion. The software integrates features from prior Biograph Vision PET/CT systems with enhanced workflows and patient handling improvements.

Performance

Performance testing for the PET subsystem was conducted according to NEMA NU 2:2018 standards with all acceptance criteria met, including spatial resolution, sensitivity, count rate performance, scatter fraction, co-registration accuracy, and time-of-flight resolution. CT performance testing was previously completed for the CT subsystem. The device also complies with multiple safety and product standards to ensure risk mitigation and cybersecurity controls.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/16/2023

    1 month
  • 2

    FDA Approval

    1/12/2024

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