Omni Legend is a PET/CT imaging system designed by GE Medical Systems Israel that produces attenuation-corrected PET images for a wide range of clinical applications including oncology, cardiology, and neurology. It assists healthcare professionals by providing high-quality functional and anatomical imaging to aid in diagnosis, treatment planning, and monitoring of various diseases and conditions. The system incorporates advanced image reconstruction and motion correction AI technologies to improve image quality and accuracy.
Intended Use
The GE Omni Legend is a PET/CT system for producing attenuation corrected PET images. It is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages, imaging the whole body and specific systems. It aids in radiotherapy treatment planning, therapy guidance, interventional radiology procedures, and functional/anatomical mapping. It supports detection, diagnosis, staging, monitoring, and follow-up of abnormalities, lesions, tumors, infection, and disease in oncology, cardiology, and neurology.
Technology
Omni Legend is a hybrid digital PET/CT system combining a GEHC Positron Emission Tomography (PET) system with a diagnostic GEHC Computed Tomography (CT) system. It features SiPM-based light sensors with ASIC on BGO scintillator crystals, multiple detector ring configurations (16, 21, 32 cm axial FOV), and a 70 cm bore. It utilizes iterative image reconstruction technology, Precision DL software, and includes PET Digital Gating (MotionFree) and an Enhanced AC option for respiratory motion correction. The system complies with IEC 60601-1 and related standards.
Performance
Extensive design control testing including bench testing per NEMA NU 2-2018 standards demonstrated system sensitivity, noise equivalent count rate, contrast recovery, spatial resolution, quantitation, and dose/time reduction. PET Digital Gating and Enhanced AC were qualitatively and quantitatively validated, showing improvement in lesion quantification. A clinical reader study confirmed acceptable diagnostic image quality and artifact correction. No new safety or effectiveness concerns were identified.
Predicate Devices
No predicate devices specified
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