PHAROS

PHAROS is a dedicated PET (Positron Emission Tomography) scanner that detects the distribution of radioactivity in specific body regions (brain, breast, arms, and legs) after injection of a positron-emitting radiopharmaceutical. It produces high-resolution 3D images to assist in diagnosis, therapeutic planning, and outcome assessment.

Both PHAROS and the predicate BBX-PET use pixelated scintillation crystals coupled to silicon photomultipliers in a circular gantry design. Key differences: PHAROS uses single-layer crystals versus the predicate's dual-layer crystals; PHAROS has a larger bore diameter (320 mm vs. 288 mm) and extended axial field-of-view; PHAROS includes Time-of-Flight functionality and a variable patient chair, whereas the predicate uses manual positioning. PHAROS demonstrates superior performance specifications (higher sensitivity, better scatter fraction control, time resolution <275 ps).

IEC 60601-1 and IEC 60601-1-2 for electrical safety and electromagnetic compatibility; NEMA NU2:2018 and NEMA NU4:2008 for PET performance; ISO 10993-1 for biocompatibility; IEC 62304 for software verification and validation; ISO 14971 for risk management.

Both devices are Class II emission computed tomography systems with identical product codes (KPS) and similar indications for use. They employ the same fundamental PET detection principle using scintillation crystals and photomultipliers in a circular configuration. Although PHAROS incorporates design improvements (single-layer crystal, larger bore, TOF capability, integrated chair) that enhance performance metrics, these differences are attributed to normal design evolution and do not introduce new safety or effectiveness risks. The device passed all required performance tests, clinical images demonstrated acceptability, and performance testing confirmed it is at least as safe and effective as the predicate.