PennPET Explorer Positron Emission Tomograph
Trustees Of The University Of PennsylvaniaThe PennPET Explorer Positron Emission Tomograph is a diagnostic imaging system that combines PET and CT imaging to detect and monitor various diseases such as cancer, heart, and brain conditions. It features a long axial field-of-view PET scanner that images large body regions in a single scan without moving the patient, providing improved sensitivity and time-of-flight resolution to help clinicians in diagnosis and treatment planning.
Intended Use
The PennPET Explorer PET system, together with the co-located IQon CT scanner, combines PET and CT imaging to detect, localize, diagnose, stage, re-stage, and monitor therapy response of various diseases in oncology, cardiology, and neurology. It images whole body and major organs and can be used independently as a diagnostic CT tool including for radiation therapy planning.
Technology
The device extends the axial field-of-view to 142 cm by combining six PET detector rings based on the Philips Vereos PET scanner technology. It uses a modular PET gantry system and co-located Philips IQon multi-energy CT, with modified sensor firmware, cooling, couch, and data processing software to handle the larger data sets and improve sensitivity and time-of-flight resolution.
Performance
Non-clinical performance testing was conducted following international and FDA recognized standards including NEMA NU 2-2018 and IEC 60601 series. Testing included design verification, image quality evaluation, risk mitigation, electromagnetic compatibility, and device safety. Clinical evaluation via simulated use and radiologist image review showed equivalence or better image quality compared to the predicate device. No new clinical studies were required.
Predicate Devices
No predicate devices specified
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