Intended Use

The Vereos PET/CT System is a diagnostic imaging device combining Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) to detect, localize, diagnose, stage, re-stage, and monitor therapy response of various diseases in oncology, cardiology, and neurology across major organs and whole body.

Technology

The system combines CT for anatomical imaging and PET for functional imaging, integrating these via Philips fusion viewer software; employs an AI-powered Adaptive Reconstruction algorithm (PET AR) which iteratively reconstructs PET images to full convergence improving noise reduction and contrast detectability; no hardware changes from predicate device; software developed according to IEC 62304 standards.

Performance

Non-clinical performance testing including design verification, image quality testing, and risk analysis demonstrated compliance with international and FDA-recognized consensus standards, showing that the device is safe, effective, and substantially equivalent to the predicate device; clinical evaluation via simulated use testing and board-certified radiologist image review confirmed good image quality; no new risks introduced by software modification.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    6/8/2021

    1 month
  • 2

    FDA Approval

    8/6/2021

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