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PHAROS is a dedicated PET scanner intended to obtain Positron Emission Tomography (PET) images of parts of human body that fit in the patient aperture (brain, breast, arms and legs) to detect abnormal patterns of distribution of radioactivity after injection of a positron emitting radiopharmaceutical. This information can assist in diagnosis, therapeutic planning and therapeutic outcome assessment.

PHAROS is a specialized high-sensitivity and high-resolution PET system designed for imaging specific organs, such as the brain, breast, arms and legs.

Positron emission tomography (PET) captures images by detecting the distribution of internal radioactivity in human organs, utilizing radioactive pharmaceuticals. This technology reconstructs the body's internal biochemical and metabolic processes, producing high-resolution 3D visualizations. The method involves measuring a pair of simultaneous gamma rays, each with an energy of 511 keV, resulting from the annihilation of positrons. By labeling the positron emitter with a tracer and using a ring-shaped gamma ray detector, the spatial location of positron-emitting nuclides within the body is visualized.

PHAROS features four different scanning modes, each tailored for specific types of imaging:

1. Brain Scan Mode (Sitting Position):
   This mode is designed for brain imaging while the patient is seated.

2. Brain Scan Mode (Lying Position):
   This mode is designed for brain imaging while the patient lies down on a bed.

3. Breast Scan Mode:
   This mode is designed for breast imaging while the patient lies in a prone position.

4. Periphery Scan Mode:
   This mode is designed for imaging the periphery of the body, including the arms, hands, legs, and knees.

For both upper and lower extremity imaging, the height of detector head can be adjusted to ensure optimal patient comfort and accurate positioning. Aside from the physical height adjustment of the detector head, there is no difference in image acquisition method or image generation algorithm between upper and lower extremity scans.

Here's a summary of the acceptance criteria and study information for the PHAROS device, based on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

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